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DURICEF

NDA

CEFADROXIL/CEFADROXIL HEMIHYDRATE | N050528 | WARNER CHILCOTT INC

1 strength0 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 (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Orchid Healthcare (A Division of Orchid Chemicals & Pha... FDA-2006-P-0387 Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals Ltd, filed this citizen petition regarding cefadroxil, an antibiotic available in multiple dosage forms including capsules, suspensions, and tablets with strengths ranging from 125 mg to 1 gram. The petition references the Reference	Other	2009-04-01	Open	Orchid Healthcare (A Division of Orchid Chemicals & Pharmaceuticals Ltd)

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1GM BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.