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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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2013-P-0947 · 4 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate an additional Reference Listed Drug for Cefdinir for Oral Suspension in the Orange Book, because the original RLD (OMN	505(q)	2013-09-16	Withdrawn	—
Citizen Petition from Lupin Pharmaceuticals, Inc. FDA-2006-P-0013 · 7 docket documents 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Tablets in strengths of 187.5 mg, 250 mg, and 300 mg suitable for submission as an abbreviated	Other	2008-08-14	Withdrawn	Lupin Pharmaceuticals, Inc.

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

Clinical Trials

25 trials from ClinicalTrials.gov — 1 recruiting, 21 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery for Pituitary Lesions NCT03014687	Phase 4	Recruiting	St. Joseph's Hospital and Medical Center, Phoenix	116	2017-07-01 → 2019-07
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions NCT00882700	Phase 1	Completed	Sandoz	28	2005-04 → 2005-04
Cefdinir Capsules 300 mg, Fasting NCT00835484	Phase 1	Completed	Teva Pharmaceuticals USA	32	2005-07 → 2005-07
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions NCT00883883	Phase 1	Completed	Sandoz	40	2005-04 → 2005-05
Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use NCT01561703	N/A	Completed	University of Missouri-Columbia	58	2012-03 → 2015-06
A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications NCT00644774	Phase 4	Completed	Abbott	157	2003-01
Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications NCT00644891	Phase 4	Completed	Abbott	158	2003-01
Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting NCT00835549	Phase 1	Completed	Teva Pharmaceuticals USA	32	2005-03 → 2005-03
A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections NCT00234949	Phase 4	Completed	Abbott	380	2005-03
Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis NCT00645073	Phase 4	Completed	Abbott	271	2003-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain11 active DMFs2 inactive

9 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

ZHEJIANG APELOA TOSPO PHARMACEUTICAL CO LTDCEFDINIR

DMF 435272026

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