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OMNICEF

NDA

CEFDINIR | N050749 | ABBVIE INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2006-P-0013 Lupin Pharmaceuticals, Inc. filed this suitability petition pursuant to 21 CFR 314.93 and section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cefdinir Chewable Tablets in strengths of 187.5 mg, 250 mg, and 300 mg suitable for submission as an abbreviated	Other	2008-08-14	Withdrawn	Lupin Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain10 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

LUPIN LTDCEFDINIR MONOHYDRATE USP

DMF 177052004

OLON SPACEFDINIR HYDRATE

DMF 179862004

SANDOZ GMBHCEFDINIR

DMF 184572005

ORCHID PHARMA LTDCEFDINIR FORM-B

DMF 194012006

APITORIA PHARMA PRIVATE LTDCEFDINIR USP (CRYSTAL B)

DMF 196072006

NECTAR LIFESCIENCES LTDCEFDINIR USP

DMF 255702011

COVALENT LABORATORIES PRIVATE LTDCEFDINIR USP

DMF 258822012

TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDCEFDINIR USP

DMF 291192015

COVALENT LABORATORIES PRIVATE LTDCEFDINIR HYDRATE USP

DMF 303202016

APITORIA PHARMA PRIVATE LTDCEFDINIR USP (ANHYDROUS)

DMF 395402024

RANBAXY LABORATORIES LTDInactiveCEFDINIR

DMF 198662006

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCEFDINIR HYDRATE

DMF 207302007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Nov 20, 2015	SUPPL -23	View Letter (PDF)
Dec 19, 2008	SUPPL -21	View Letter (PDF)
Sep 25, 2007	SUPPL -18	View Letter (PDF)
Jul 5, 2007	SUPPL -17	View Letter (PDF)
Jul 21, 2005	SUPPL -13	View Letter (PDF)
Sep 3, 2004	SUPPL -9	View Letter (PDF)
Jul 30, 2004	SUPPL -10	View Letter (PDF)
Jul 14, 1999	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Dec 4, 1997

No patent or exclusivity listings for this strength.

#002 — 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Jul 29, 2004