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CEFDINIR

ANDA

CEFDINIR | A065429 | ANDA REPOSITORY LLC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition 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Listed Drug for Cefdinir for Oral Suspension in the Orange Book, because the original RLD (OMN	505(q)	2013-09-16	Withdrawn	—

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

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.

Products (2)

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#001 — 125MG/5ML

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Jul 18, 2007

No patent or exclusivity listings for this strength.

#002 — 250MG/5ML

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Jul 18, 2007