ELIQUIS

FDA-2026-P-4800

Unison Pharmaceuticals Pvt. Ltd. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Orally Disintegrating Tablets 2.5 mg and 5 mg suitable for submission as an Abbreviated New Drug Application, with the reference p

FDA-2026-P-0126

Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Tablets for Oral Suspension, 2.5 mg, suitable for submission in an Abbreviated New Drug Application, with

FDA-2024-P-4890

Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Apixaban Oral Suspension, 1.25 mg/mL suitable for submission as an ANDA under section 505(j)(2)(C) of the FD&C Act, with the reference drug being ELIQUIS tablets (2.5 mg and 5 mg)

FDA-2024-P-0526

Lupin, Inc. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Oral Suspension, 1.25 mg/mL suitable for consideration in an ANDA, with the reference drug product being ELIQUIS (apixaban) Tablets by Bri

FDA-2017-P-6020

The law firm Axinn, Veltrop & Harkrider LLP filed this suitability petition on October 3, 2017, requesting that the FDA declare Apixaban Tablets, 10 mg, suitable for submission in an ANDA under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, with the reference listed drug being Eli

FDA-2016-P-3463

Axinn, Veltrop & Harkrider LLP filed a suitability petition regarding proposed prescribing information for apixaban tablets as a supplement to an Abbreviated New Drug Application, seeking FDA review and approval of the proposed labeling for this generic anticoagulant product.

FDA-2016-P-3463

Axinn, Veltrop & Harkrider LLP filed this ANDA suitability petition on behalf of a client pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Apixaban Tablets, 10 mg, suitable for submission in an ANDA with Eliquis (apixaban) Tablets, 2.5 mg a

FDA-2016-P-3463

FDA-2016-P-3463

The law firm Axinn, Veltrop & Harkrider LLP filed a petition regarding Eliquis (apixaban) tablets in 2.5 mg and 5 mg strengths, requesting determination of suitability for abbreviated new drug application (ANDA) approval based on the Orange Book listing for this anticoagulant product.

FDA-2016-P-3463

This document is an attachment containing approved labeling for Eliquis (apixaban) tablets under NDA 202155 held by Bristol Myers Squibb, submitted in connection with a suitability petition filed by the law firm Axinn, Veltrop & Harkrider LLP. The attachment itself consists of the product labeling a

FDA-2015-P-3408

David Cundiff filed this citizen petition under 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA designate all anticoagulants including heparin, low molecular weight heparins, fondaparinux, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for patien

FDA-2015-P-3410

David K. Cundiff filed this petition under the Federal Food, Drug, and Cosmetic Act section 355(e)(3) on September 25, 2015, requesting that the FDA withdraw approval and designate all oral anticoagulants including warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for non-

FDA-2015-P-2373

David K. Cundiff, MD filed this petition under 21 U.S.C. Section 355(e)(3) requesting that the FDA revoke approval and add contraindication labels for all anticoagulant drugs including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban for the treatment of venous thromboembolism (dee