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LOCOID LIPOCREAM

NDA

HYDROCORTISONE BUTYRATE | N020769 | PRECISION DERMATOLOGY 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF1 inactive

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

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE BUTYRATE USP

DMF 315442017

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveHYDROCORTISONE BUTYRATE

DMF 104471993

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Oct 4, 2024	SUPPL -15	View Letter (PDF)
Nov 24, 2014	SUPPL -14	View Letter (PDF)
Oct 26, 2009	SUPPL -11	View Letter (PDF)
Apr 24, 2006	SUPPL -9	View Letter (PDF)
Aug 25, 2004	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLDAB2

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Sep 8, 1997

No patent or exclusivity listings for this strength.