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WESTCORT

NDA

HYDROCORTISONE VALERATE | N018726 | SUN PHARMACEUTICAL INDUSTRIES 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

LUPIN LTDHYDROCORTISONE VALERATE USP

DMF 311432016

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDHYDROCORTISONE VALERATE USP

DMF 314232017

TRIFARMA SPAHYDROCORTISONE VALERATE

DMF 333342018

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE VALERATE USP

DMF 309712016

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 3, 2002	SUPPL -9	View Letter (PDF)
Sep 21, 2000	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Aug 8, 1983

No patent or exclusivity listings for this strength.