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CEFDINIR

ANDA

CEFDINIR | A065337 | CHARTWELL RX SCIENCES LLC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ApicHope Pharmaceuticals (USA) Limited FDA-2022-P-0833 ApicHope Pharmaceutical (USA) Limited filed this citizen petition on May 18, 2022, requesting that the FDA determine whether the reference standard cefdinir powder for suspension (125 mg/5 mL and 250 mg/5 mL) manufactured by Sandoz under ANDA 065337 was discontinued or withdrawn for safety or effect	505(q)	2022-05-18	Withdrawn	ApicHope Pharmaceuticals (USA) Limited

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

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.

Products (2)

Sort:

#001 — 125MG/5ML

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Apr 6, 2007

No patent or exclusivity listings for this strength.

#002 — 250MG/5ML

0 patents0 exclusivities▾

FOR SUSPENSION;ORAL | Approved: Apr 6, 2007