Viewing data from:

LOCOID

NDA

HYDROCORTISONE BUTYRATE | N019116 | BAUSCH HEALTH AMERICAS 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 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

1 letter from Drugs@FDA

Date	Submission	Document
Oct 31, 2014	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLDAT

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Feb 25, 1987

No patent or exclusivity listings for this strength.