Viewing data from:

BETA-VAL

NDA

BETAMETHASONE VALERATE | N018642 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

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 Chain5 active DMFs8 inactive

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

TAPI NL BVBETAMETHASONE VALERATE

DMF 41181981

FARMABIOS SPABETAMETHASONE VALERATE

DMF 127491997

HALCYON LABS PRIVATE LTDBETAMETHASONE VALERATE USP

DMF 213202008

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE VALERATE

DMF 358652022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDBETAMETHASONE VALERATE

DMF 380632023

GLAXOCHEM LTDInactiveBETAMETHASONE VALERATE

DMF 45781982

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE VALERATE USP XX

DMF 54651984

DIOSYNTH BVInactiveBETAMETHASONE VALERATE

DMF 55541984

SCHERING AGInactiveBETAMETHASONE VALERATE

DMF 58631985

PFIZER INCInactiveBETAMETHASONE VALERATE

DMF 64051986

QUATRUMInactiveBETAMETHASONE VALERATE

DMF 70491987

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE VALERATE USP, BP

DMF 73101988

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBETAMETHASONE VALERATE USP

DMF 226512008

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

Products (1)

#001 — EQ 0.1% BASE

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Mar 24, 1983

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name from "Cosette" to "Cosette Pharms NC" for betamethasone valerate (Beta-Val) NDA 018642.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its corporate name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the betamethasone valerate (Beta-Val) NDA 018642.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC