On August 26, 2026, the U.S. Food and Drug Administration (FDA) published a formal notice in the Federal Register (Document 2026-17401; Docket No. FDA-2026-P-3104) issuing a determination under 21 CFR 314.161 that CABAZITAXEL solution (injection), 60 mg/6 mL (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.
The notice follows a citizen petition submitted on March 24, 2026, by Steve Jensen of ProPharma. The Federal Register notice does not identify a client behind that petition. In automated trade newsfeeds and oncology market digests, the publication was quickly summarized under alarmist headlines suggesting that cabazitaxel or Sanofi's reference brand Jevtana was subject to a safety withdrawal.
For regulatory affairs attorneys, hospital oncology pharmacy directors, generic portfolio planners, and market-access teams, that reading completely misinterprets the statutory mechanism:
Does the August 26 Federal Register notice indicate that brand Jevtana is being removed from the market, does it unlock an immediate generic substitute for Sanofi's 40 mg/mL two-vial kit, or does it merely establish ANDA eligibility for a discontinued 10 mg/mL 505(b)(2) formulation?
The direct regulatory answer is that the notice applies exclusively to a discontinued 10 mg/mL 505(b)(2) application and has zero impact on Jevtana kit's marketing status or pharmacy substitution:
- The listed drug evaluated is Teva's discontinued 10 mg/mL NDA, not Sanofi's Jevtana kit. The determination applies strictly to NDA 207970, held by Actavis LLC (an indirect wholly owned subsidiary of Teva Pharmaceuticals), approved on March 14, 2024 as a Type 5 new formulation (60 mg/6 mL [10 mg/mL] single-vial injection) and discontinued by letter dated September 6, 2024—after being marketed for barely six months.
- Jevtana kit remains fully marketed with active, AP-rated generic ANDAs. Sanofi's reference listed drug (NDA 201023; 60 mg/1.5 mL [40 mg/mL] kit) remains active in the Prescription (RX) section of the Orange Book. Two generic competitors—Accord Healthcare (ANDA 207693) and Dr. Reddy's Laboratories (ANDA 207718)—are actively marketing AP-rated generic kit presentations that substitute directly for brand Jevtana under state pharmacy practice acts.
- An approved ANDA referencing NDA 207970 will not substitute for Jevtana kit. Under FDA therapeutic equivalence principles and state substitution laws, a future ANDA referencing NDA 207970 will be coded AP only against the 10 mg/mL single-vial listed drug. It cannot be substituted by a dispensing pharmacist when a clinician prescribes 40 mg/mL Jevtana kit or its AP-rated generic equivalents.
- The 314.161 finding satisfies Hatch-Waxman statutory eligibility but does not resolve patent barriers. While NDA 207970 lists zero patents in the Orange Book, Sanofi's reference kit NDA 201023 lists method-of-use patents extending through October 27, 2030 (with pediatric exclusivity through April 27, 2031). ANDA filers referencing the 10 mg/mL presentation must still navigate potential patent infringement assertions covering cabazitaxel dosing in metastatic castration-resistant prostate cancer (mCRPC).
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ CABAZITAXEL ORANGE BOOK FORMULATION & APPLICATION CENSUS │
├────────────┬────────────────────────┬─────────────┬───────────┬──────────────┬───────────────┤
│ Appl No. │ Applicant / Sponsor │ Formulation │ Strength │ TE Code │ Type / Approval │
├────────────┼────────────────────────┼─────────────┼───────────┼──────────────┼───────────────┤
│ NDA 201023 │ Sanofi-Aventis (Jevtana)│ Two-Vial Kit│ 60mg/1.5mL│ AP (RLD/RS) │ RX Jun 17, 2010│
│ │ │ │ (40 mg/mL)│ │ │
│ ANDA 207693│ Accord Healthcare │ Two-Vial Kit│ 60mg/1.5mL│ AP │ RX Oct 26, 2022│
│ │ │ │ (40 mg/mL)│ │ │
│ ANDA 207718│ Dr. Reddy's Labs │ Two-Vial Kit│ 60mg/1.5mL│ AP │ RX Feb 10, 2023│
│ │ │ │ (40 mg/mL)│ │ │
│ ANDA 207381│ Mylan │ Two-Vial Kit│ 60mg/1.5mL│ [BLANK] │ DISCN Jul 5, │
│ │ │ │ (40 mg/mL)│ │ 2023 │
│ ANDA 207619│ Breckenridge │ Two-Vial Kit│ 60mg/1.5mL│ [BLANK] │ DISCN Jun 23, │
│ │ │ │ (40 mg/mL)│ │ 2022 │
│ ANDA 207736│ Apotex Inc. │ Two-Vial Kit│ 60mg/1.5mL│ [BLANK] │ DISCN Feb 10, │
│ │ │ │ (40 mg/mL)│ │ 2023 │
│ NDA 207949 │ Accord Healthcare │ Single-Vial │ 60mg/3mL │ [BLANK] │ DISCN Dec 29, │
│ │ Type 5 / 505(b)(2) │ │ (20 mg/mL)│ (RLD Yes) │ 2021 │
│ NDA 207970 │ Actavis LLC (Teva) │ Single-Vial │ 60mg/6mL │ [BLANK] │ DISCN Mar 14, │
│ │ Type 5 / 505(b)(2) │ │ (10 mg/mL)│ (RLD Yes) │ 2024 │
└────────────┴────────────────────────┴─────────────┴───────────┴──────────────┴───────────────┘
Below, we parse the statutory framework under 21 CFR 314.161, audit the complete cabazitaxel landscape across FDA datasets, detail the preparation and medication-error warnings separating single-vial from two-vial presentations, and assess the commercial economics governing generic taxane access.
Statutory Decoding: 21 CFR 314.161 and the ProPharma Citizen Petition
Under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), an Abbreviated New Drug Application (ANDA) must reference a drug product that has been approved under Section 505(c) (a Listed Drug). When a sponsor voluntarily ceases marketing an approved drug and moves it to the Discontinued Drug Product List, the Hatch-Waxman statutory machinery requires a formal administrative checkpoint:
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ 21 CFR 314.161 ADMINISTRATIVE DETERMINATION PROCESS │
├──────────────────────────────────────────────────────────────────────────────────────────────┤
│ │
│ [ March 14, 2024: FDA Approves NDA 207970 (Actavis 10 mg/mL Single-Vial Cabazitaxel) ] │
│ │ │
│ ▼ │
│ [ September 6, 2024: Actavis Formally Notifies FDA of Voluntary Commercial Discontinuation]│
│ │ │
│ ▼ │
│ [ March 24, 2026: ProPharma (Steve Jensen) Files Citizen Petition FDA-2026-P-3104 ] │
│ • Requests FDA determine whether NDA 207970 was withdrawn for safety or efficacy │
│ • Submitted under 21 CFR 10.30 and 21 CFR 314.161 to unblock ANDA submission │
│ │ │
│ ▼ │
│ [ August 26, 2026: FDA Publishes FR 2026-17401 Finding ] │
│ ✔ Finding: NDA 207970 was NOT withdrawn for reasons of safety or effectiveness. │
│ ✔ Regulatory Consequence: FDA may approve ANDAs that reference NDA 207970 as Listed Drug. │
│ ✔ Product Status: Remains on Discontinued Drug Product List; does NOT restore RS status. │
│ │
└──────────────────────────────────────────────────────────────────────────────────────────────┘
- The 21 CFR 314.161 Rule: Under 21 CFR 314.161(a), if a listed drug is voluntarily withdrawn from sale, FDA must determine whether the product was discontinued for reasons of safety or effectiveness before approving an ANDA that refers to that listed drug.
- The Citizen Petition Trigger: Steve Jensen of ProPharma filed citizen petition FDA-2026-P-3104 on March 24, 2026, asking FDA to determine whether NDA 207970 was withdrawn for safety or effectiveness. The FR notice does not name a generic client.
- The Agency Determination: In Document 2026-17401, FDA determined under § 314.161 that the 10 mg/mL product was not withdrawn for reasons of safety or effectiveness. The notice does not state a commercial motive. FDA will continue to list the product on the Discontinued Drug Product List, and ANDAs that refer to this listed drug may be approved if all other legal and regulatory requirements are met.
As analyzed in our foundational framework on discontinued RLDs and reference standard workflows, a 314.161 determination does not return the discontinued product to the active Prescription list. It remains in the Discontinued section with a designated footnote indicating safety clearance.
Complete Orange Book Census: Eight Cabazitaxel Applications
To evaluate the competitive structure of the cabazitaxel market, we executed a complete census of the FDA Orange Book product dataset (product file dated August 14, 2026; 48,664 total product records).
The query isolates exactly 8 cabazitaxel product listings across 8 unique application numbers:
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ COMPLETE FDA ORANGE BOOK CABAZITAXEL APPLICATION ROSTER │
├────────────┬─────────────┬────────────────────────┬─────────────┬───────────┬────────────────┤
│ Appl No. │ App Type │ Applicant Sponsor │ Strength │ TE Rating │ Marketing Stat │
├────────────┼─────────────┼────────────────────────┼─────────────┼───────────┼────────────────┤
│ NDA 201023 │ 505(b)(1) │ Sanofi-Aventis (Jevtana│ 60mg/1.5mL │ AP (RLD/RS│ Prescription │
│ ANDA 207693│ 505(j) │ Accord Healthcare │ 60mg/1.5mL │ AP │ Prescription │
│ ANDA 207718│ 505(j) │ Dr. Reddy's Labs │ 60mg/1.5mL │ AP │ Prescription │
│ ANDA 207381│ 505(j) │ Mylan (Viatris) │ 60mg/1.5mL │ [BLANK] │ Discontinued │
│ ANDA 207619│ 505(j) │ Breckenridge Pharma │ 60mg/1.5mL │ [BLANK] │ Discontinued │
│ ANDA 207736│ 505(j) │ Apotex Inc. │ 60mg/1.5mL │ [BLANK] │ Discontinued │
│ NDA 207949 │ 505(b)(2) │ Accord Healthcare │ 60mg/3mL │ [BLANK] │ Discontinued │
│ NDA 207970 │ 505(b)(2) │ Actavis LLC (Teva) │ 60mg/6mL │ [BLANK] │ Discontinued │
└────────────┴─────────────┴────────────────────────┴─────────────┴───────────┴────────────────┘
Critical Findings from the Census:
- Marketed Generic Penetration on the 40 mg/mL Kit: Two generic manufacturers—Accord Healthcare (approved October 26, 2022) and Dr. Reddy's Laboratories (approved February 10, 2023)—remain RX and AP-rated in the August 14, 2026 Orange Book for Sanofi's 60 mg/1.5 mL kit. That is a listing fact, not a hospital volume share.
- Three Discontinued Generic Kit ANDAs: Three other generic filers—Mylan (ANDA 207381, approved July 5, 2023), Breckenridge (ANDA 207619, approved June 23, 2022), and Apotex (ANDA 207736, approved February 10, 2023)—are listed as DISCN with blank TE. Orange Book approval dates are not discontinuation dates; the files do not state why those ANDAs left the market.
- Two Discontinued 505(b)(2) Concentrations: In addition to Teva's 10 mg/mL presentation (NDA 207970), Accord Healthcare won approval on December 29, 2021 for a 20 mg/mL formulation (NDA 207949; 60 mg/3 mL), which it subsequently discontinued. Notably, Accord's 20 mg/mL NDA was not included in this week's Federal Register notice.
- Drugs@FDA Database Discrepancy: Cross-referencing the Drugs@FDA relational extract dated August 16, 2026 shows therapeutic-equivalence rows still carrying AP codes for discontinued ANDAs 207381, 207619, and 207736 with MarketingStatusID 1, while the marketing-status table flags those applications as Discontinued (MarketingStatusID 3) and the active Orange Book file lists them under DISCN with blank TE. Industry analysts must not mistake the stale relational TE rows for active commercial availability.
The Formulation Divide: Single-Vial 10 mg/mL vs. Two-Vial 40 mg/mL Kit
To understand why Actavis developed NDA 207970—and why generic filers might still pursue it—one must examine the clinical preparation and medication-safety differences between the formulations.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ CABAZITAXEL COMPOUNDING & PREPARATION WORKFLOW MATRIX │
├─────────────────────────────────────┬────────────────────────────────────────────────────────┤
│ Preparation Parameter │ Jevtana Two-Vial Kit (40 mg/mL) vs. NDA 207970 (10mg/mL)│
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ Packaging Configuration │ Concentrated vial (1.5 mL) + Diluent vial (5.7 mL) │
│ Initial Compounding Step │ Must inject entire diluent into concentrate to create │
│ │ an intermediate 10 mg/mL premix solution. │
│ Secondary Compounding Step │ Withdraw calculated dose from premix and inject into │
│ │ infusion bag (0.9% NaCl or 5% Dextrose). │
│ NDA 207970 One-Vial Method │ Bypasses Step 1 entirely: Withdraw 10 mg/mL solution │
│ │ directly from the single vial into infusion bag. │
│ Labeled Medication-Error Warning │ "Do not combine the two-vial formulation with the │
│ (NDA 207970 Section 2.5) │ one-vial formulation. Preparation steps differ." │
└─────────────────────────────────────┴────────────────────────────────────────────────────────┘
- The Complex Two-Vial Kit Workflow: Sanofi's original Jevtana formulation (NDA 201023) is packaged as a two-vial kit containing 60 mg/1.5 mL cabazitaxel concentrate and a separate 5.7 mL diluent vial (13% ethanol in water). Hospital oncology cleanrooms must execute a two-step dilution process: first mixing the diluent with the concentrate to create an intermediate 10 mg/mL solution, then withdrawing the patient-specific dose to inject into an infusion container.
- The Single-Vial 505(b)(2) Innovation: Actavis developed NDA 207970 as a Type 5 New Formulation (ready-to-dilute), formulating the drug directly at 10 mg/mL (60 mg/6 mL) in a single vial. This eliminated the initial reconstitution step, saving cleanroom compounding time and reducing compounding error risks.
- The Explicit Label Warning: Multiple concentrations create a medication-error hazard. Highlights and Section 2.5 of the NDA 207970 prescribing information instruct:
"To avoid medication errors, do not combine the two-vial formulation (injection and diluent) with the one vial formulation."
That instruction is a dosage-and-administration warning, not the product's boxed warning (neutropenia). Treating a 40 mg/mL kit as a 10 mg/mL single vial, or the reverse, is a concentration mix-up. This article does not provide compounding instructions.
Therapeutic Equivalence: Why a 10 mg/mL ANDA Cannot Substitute for Jevtana
A vital principle of generic regulation—reinforced in our analysis of the FDA's August 2026 Therapeutic Equivalence Final Guidance—is that therapeutic equivalence requires pharmaceutical equivalence.
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ THERAPEUTIC EQUIVALENCE & PHARMACY SUBSTITUTION BOUNDARIES │
├──────────────────────────────────────────────────────────────────────────────────────────────┤
│ │
│ [ Prescriber Writes: "Jevtana Kit 60 mg IV" or "Cabazitaxel Kit 60 mg/1.5 mL" ] │
│ │ │
│ ┌─────────────────────────────────────┴─────────────────────────────────────┐ │
│ ▼ ▼ │
│ [ LAWFUL PHARMACY SUBSTITUTION ] [ UNLAWFUL AUTOMATIC SWITCH ] │
│ Pharmacist dispenses AP-rated generic kit: Pharmacist dispenses future │
│ ✔ Accord ANDA 207693 (40 mg/mL Kit) ANDA to NDA 207970 (10 mg/mL) │
│ ✔ Dr. Reddy's ANDA 207718 (40 mg/mL Kit) ✖ Violates state substitution │
│ (Permitted under State Generic Substitution Acts) laws (Different strength/vial)│
│ ✖ Requires new prescription │
│ │
└──────────────────────────────────────────────────────────────────────────────────────────────┘
- Pharmaceutical Equivalence Standard: To be pharmaceutically equivalent under 21 CFR 320.1, drug products must contain the same active ingredient in the same dosage form, route of administration, and strength or concentration.
- The AP Rating Isolation: An ANDA referencing NDA 207970 will be coded AP only against NDA 207970 (the 10 mg/mL listed drug). It will not be pharmaceutically equivalent to NDA 201023 (the 40 mg/mL kit).
- State Substitution Laws: A 10 mg/mL product is not pharmaceutically equivalent to a 40 mg/mL kit. Automatic substitution when Jevtana kit is prescribed would not follow Orange Book AP coding against NDA 201023. Dispensing a 10 mg/mL product requires an order written for that concentration or an institutional interchange protocol.
Patent Landscape: Jevtana Kit Use Patents vs. Dead NDA Records
Generic filers evaluating whether to submit an ANDA referencing NDA 207970 must look beyond the Orange Book listings of the reference drug.
An audit of the Orange Book patent file (August 14, 2026) reveals a striking contrast:
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ CABAZITAXEL ORANGE BOOK PATENT & EXCLUSIVITY COMPARISON │
├────────────┬─────────────┬─────────────┬─────────────────┬──────────────────┬────────────────┤
│ Appl No. │ Patent No. │ Patent Type │ Base Expiration │ Pediatric Ext. │ Listed in OB? │
├────────────┼─────────────┼─────────────┼─────────────────┼──────────────────┼────────────────┤
│ NDA 201023 │ US 7241907 │ Drug Subst. │ December 10,2025│ June 10, 2026 │ YES (expired) │
│ NDA 201023 │ US 8927592 │ Method/Use │ October 27, 2030│ April 27, 2031 │ YES (Jevtana) │
│ NDA 201023 │ US 10583110 │ Method/Use │ October 27, 2030│ April 27, 2031 │ YES (Jevtana) │
│ NDA 201023 │ US 10716777 │ Method/Use │ October 27, 2030│ April 27, 2031 │ YES (Jevtana) │
│ NDA 201023 │ US 12453712 │ Method/Use │ October 27, 2030│ April 27, 2031 │ YES (Jevtana) │
├────────────┼─────────────┼─────────────┼─────────────────┼──────────────────┼────────────────┤
│ NDA 207970 │ NONE │ — │ — │ — │ 0 PATENTS LIST │
└────────────┴─────────────┴─────────────┴─────────────────┴──────────────────┴────────────────┘
- Zero Patents on NDA 207970: The August 14, 2026 Orange Book patent file lists 0 patents on NDA 207970. That is a listing fact, not proof that no proprietary patents exist outside the Orange Book.
- Use Patents on Jevtana (NDA 201023): Sanofi lists four method-of-use patents against Jevtana kit (8,927,592; 10,583,110; 10,716,777; and 12,453,712), with expire text October 27, 2030 and pediatric extensions through April 27, 2031. Drug-substance patent 7,241,907 is listed with expire text December 10, 2025 and pediatric extension June 10, 2026; as of this article's August 27, 2026 as-of date that pediatric date has passed.
- Patent Freedom vs. Listing Silence: Generic sponsors must recognize that the absence of patents listed against NDA 207970 in the Orange Book does not provide an automatic freedom-to-operate clearance. If Sanofi asserts its method-of-use patents covering cabazitaxel co-administration with prednisone in mCRPC, an ANDA referencing NDA 207970 could face patent infringement litigation unless the generic applicant successfully carves out patented indications under Section 505(j)(2)(A)(viii) or defends against infringement.
Commercial Viability and Market-Access Strategy
Why would a generic pharmaceutical company file a citizen petition to unlock ANDA submissions for a product that Teva abandoned after six months?
┌──────────────────────────────────────────────────────────────────────────────────────────────┐
│ COMMERCIAL VIABILITY & ACCESS DECISION MATRIX │
├─────────────────────────────────────┬────────────────────────────────────────────────────────┤
│ Market Driver │ Commercial Analysis & Reality Check │
├─────────────────────────────────────┼────────────────────────────────────────────────────────┤
│ Channel Price Erosion │ Two RX AP kit ANDAs already sit next to Jevtana; │
│ │ additional 10 mg/mL ANDAs would not inherit that AP │
│ │ code against the kit. │
│ Discontinuation Precedents │ Three kit ANDAs (Mylan, Breckenridge, Apotex) are │
│ │ DISCN in the Orange Book; the files do not state why. │
│ Compounding Safety Preference │ Niche hospital systems prefer single-vial ready-to-use │
│ │ presentations to reduce oncology cleanroom labor. │
│ Injectable Oncology Shortage Hedge │ Ready-to-dilute 10 mg/mL serves as a backup inventory │
│ │ buffer during multi-vial kit supply chain crunches. │
└─────────────────────────────────────┴────────────────────────────────────────────────────────┘
- Commodity Economics: Two AP-rated kit ANDAs have been listed since 2022–2023. As noted in the site's Sanofi portfolio dossier, Jevtana already faced multiple ANDA applicants; that dossier's brand-kit WAC line should be re-checked before reuse. A 10 mg/mL ANDA would still be a different, non-substitutable concentration.
- Why Teva Discontinued NDA 207970: The FR notice records a September 6, 2024 discontinuation letter. FDA did not publish a commercial rationale. A 314.161 finding means the withdrawal was not for safety or effectiveness; it does not reconstruct Teva's business case.
- The Remaining Question for 10 mg/mL ANDAs: A future applicant could still see hospital demand for a one-vial 10 mg/mL presentation even without kit substitution. That is a commercial hypothesis, not a forecast.
For broader oncology market-access context, see our landscape analysis on prostate cancer treatment access across oral ARPIs and taxanes.
Frequently Asked Questions
Did FDA withdraw Jevtana from the market for safety reasons?
No. Sanofi's reference brand Jevtana kit (NDA 201023) remains fully marketed, FDA-approved, and listed in the Prescription section of the Orange Book alongside two AP-rated generic kit competitors. The August 26 notice applies exclusively to a discontinued 10 mg/mL 505(b)(2) application (NDA 207970) held by Actavis LLC (Teva).
Can pharmacies auto-substitute a future 10 mg/mL ANDA for Jevtana kit?
No. Under FDA therapeutic equivalence standards and state pharmacy practice acts, an ANDA referencing the 10 mg/mL listed drug (NDA 207970) will be rated AP only against that 10 mg/mL listed drug. It is not pharmaceutically equivalent to the 40 mg/mL two-vial kit (NDA 201023) and cannot be automatically substituted when Jevtana kit is prescribed.
Are there already AP-rated generic versions of Jevtana kit on the market?
Yes. Accord Healthcare (ANDA 207693) and Dr. Reddy's Laboratories (ANDA 207718) market approved, AP-rated generic versions of the 60 mg/1.5 mL kit that are actively utilized in hospital and clinic buy-and-bill channels.
Who petitioned FDA, and when was NDA 207970 discontinued?
Steve Jensen of ProPharma Group submitted citizen petition FDA-2026-P-3104 on March 24, 2026, requesting the safety determination. Actavis LLC originally won approval for NDA 207970 on March 14, 2024, and voluntarily notified the FDA of commercial discontinuation on September 6, 2024.
Sources
- Federal Register / Food and Drug Administration. Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 mg/6 mL (10 mg/mL), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Document 2026-17401; Docket No. FDA-2026-P-3104. Published August 26, 2026. https://www.federalregister.gov/documents/2026/08/26/2026-17401/determination-that-cabazitaxel-cabazitaxel-solution-injection-60-milligrams6-milliliters-10.
- Electronic Code of Federal Regulations (eCFR). 21 CFR § 314.161: Determination of reasons for voluntary withdrawal of a listed drug. Title 21, Chapter I, Subchapter D, Part 314. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-D/section-314.161.
- U.S. Food and Drug Administration. Drugs@FDA: NDA 207970 (CABAZITAXEL injection, 60 mg/6 mL). Application Tracking and Approval History. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207970.
- U.S. Food and Drug Administration / Actavis LLC. CABAZITAXEL injection, for intravenous use: Prescribing Information (NDA 207970). March 14, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207970s000lbl.pdf.
- U.S. Food and Drug Administration. Drugs@FDA: NDA 201023 (JEVTANA KIT). Application History and Reference Listed Drug Status. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201023.
- U.S. Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book Data Files). Products, Patents, and Exclusivity files current through August 14, 2026. https://www.fda.gov/media/76860/download.
