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NDA

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE | N050741 | STIEFEL LABORATORIES 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceuticals Inc FDA-2014-P-1065 Zydus Pharmaceuticals (USA), Inc. filed this citizen petition requesting that the FDA determine an NDA-authorized generic Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/5% marketed by Prasco Laboratories is suitable as an alternate Reference Listed Drug for bioequivalence testing, because the o	Other	2014-07-30	Granted	Zydus Pharmaceuticals Inc

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Apr 17, 2015	SUPPL -24	View Letter (PDF)
Dec 31, 2013	SUPPL -21	View Letter (PDF)
Jun 11, 2013	SUPPL -20	View Letter (PDF)
Dec 28, 2011	SUPPL -19	View Letter (PDF)
Nov 10, 2010	SUPPL -15	View Letter (PDF)
Jul 24, 2008	SUPPL -11	View Letter (PDF)
Nov 25, 2003	SUPPL -4	View Letter (PDF)
Oct 24, 2003	SUPPL -3	View Letter (PDF)
Apr 28, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%;1.2%

RLDAB

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Aug 26, 2002

No patent or exclusivity listings for this strength.