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NDA

ROFECOXIB | N021052 | MERCK RESEARCH LABORATORIES DIV MERCK CO 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

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SHASUN CHEMICALS AND DRUGS LTDInactiveROFECOXIB

DMF 166172003

AARTI DRUGS LTDInactiveROFECOXIB

DMF 298582015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
May 11, 2016	SUPPL -24	View Letter (PDF)
Sep 16, 2004	SUPPL -21	View Letter (PDF)
Aug 25, 2004	SUPPL -19	View Letter (PDF)
Jun 30, 2004	SUPPL -8	View Letter (PDF)
Jun 30, 2004	SUPPL -9	View Letter (PDF)
Dec 19, 2003	SUPPL -17	View Letter (PDF)
Aug 15, 2003	SUPPL -12	View Letter (PDF)
Jul 6, 2003	SUPPL -14	View Letter (PDF)
Jul 6, 2003	SUPPL -15	View Letter (PDF)
Jul 6, 2003	SUPPL -16	View Letter (PDF)
Apr 11, 2002	SUPPL -4	View Letter (PDF)
Apr 11, 2002	SUPPL -6	View Letter (PDF)
Apr 11, 2002	SUPPL -5	View Letter (PDF)
Apr 11, 2002	SUPPL -7	View Letter (PDF)
May 20, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 12.5MG/5ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: May 20, 1999

No patent or exclusivity listings for this strength.

#002 — 25MG/5ML

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: May 20, 1999