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BETAMETHASONE DIPROPIONATE

ANDA

BETAMETHASONE DIPROPIONATE | A210217 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BETAMETHASONE DIPROPIONATE(TE code: AB)

API Supply Chain9 active DMFs6 inactive

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

TAPI NL BVBETAMETHASONE DIPROPIONATE

DMF 41481981

TARO PHARMACEUTICAL INDUSTRIES LTDBETAMETHASONE DIPROPIONATE USP, MICRONIZED

DMF 146511999

CURIA SPAIN SAUBETAMETHASONE DIPROPIONATE

DMF 170462003

HALCYON LABS PRIVATE LTDBETAMETHASONE DIPROPIONATE USP

DMF 205822007

FARMABIOS SPABETAMETHASONE DIPROPIONATE MICRONIZED

DMF 231182009

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDBETAMETHASONE DIPROPIONATE

DMF 244862010

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE DIPROPIONATE

DMF 257982012

TIANJIN TIANYAO PHARMACEUTICALS CO LTDBETAMETHASONE DIPROPIONATE USP

DMF 352322020

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE DIPROPIONATE

DMF 358532021

GLAXOCHEM LTDInactiveBETAMETHASONE DIPROPIONATE PRODUCED IN THE MONTROSE, SCOTLAND PLANT

DMF 51571983

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE DIPROPIONATE

DMF 67261986

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveBETAMETHASONE DIPROPIONATE

DMF 70951987

QUATRUMInactiveBETAMETHASONE DIPROPIONATE

DMF 71251987

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE DIPROPIONATE

DMF 73891988

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBETAMETHASONE DIPROPIONATE USP

DMF 226492008

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

Products (1)

#001 — EQ 0.05% BASE

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Oct 12, 2018

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 Dipropionate (NDA 210217).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the betamethasone dipropionate NDA 210217.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC