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DEXAMETHASONE

ANDA

DEXAMETHASONE | A088254 | PHARMOBEDIENT CONSULTING

1 strength0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs18 inactive

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

EUROAPI FRANCEDEXAMETHASONE

DMF 17481971

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCDEXAMETHASONE USP MICRONIZED

DMF 45241982

MAHIMA LIFE SCIENCES PRIVATE LTDDEXAMETHASONE USP

DMF 278882013

FARMABIOS SPADEXAMETHASONE USP

DMF 315322017

TIANJIN TIANYAO PHARMACEUTICALS CO LTDDEXAMETHASONE BULK API

DMF 348102020

TIANJIN TIANYAO PHARMACEUTICALS CO LTDDEXAMETHASONE SODIUM PHOSPHATE, BULK API

DMF 348112020

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 362702022

SHANDONG SIRUI PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 368942022

SYMBIOTEC PHARMALAB PRIVATE LTDDEXAMETHASONE USP

DMF 381622023

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDEXAMETHASONE

DMF 409942024

ORGANON INCInactiveDEXAMETHASONE

DMF 5191963

ORGANON INCInactiveDEXAMETHASONE

DMF 5421963

ORGANON INCInactiveDEXAMETHASONE 21-PHOSPHATE

DMF 5821963

SF DURST AND CO INCInactiveDEXAMETHASONE

DMF 10951967

ORGANON INCInactiveDEXAMETHASONE 21-TERTIARY BUTYLACETATE

DMF 13431969

ANTIBIOTICOS SPAInactiveDEXAMETHASONE SODIUM PHOSPHATE BULK

DMF 23781974

ROUSSEL CORPInactiveDEXAMETHASONE SODIUM METASULFOBENZOATE

DMF 27371976

ORGANON INCInactiveDEXAMETHASONE

DMF 28161976

BLASCHIM SPAInactiveDEXAMETHASONE 21 SODIUM PHOSPHATE

DMF 28491977

ANTIBIOTICOS SPAInactiveDEXAMETHASONE 21-SODIUM M-SULFOBENZOATE

DMF 36841980

BLASCHIM SPAInactiveDEXAMETHASONE

DMF 36861980

CYCLO PRODUCTS INCInactiveDEXAMETHASONE

DMF 37331980

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveDEXAMETHASONE BASE, USP XX

DMF 42851981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveDEXAMETHASONE SODIUM PHOSPHATE USP XX

DMF 44971982

DIOSYNTH BVInactiveDEXAMETHASONE MICRO AND NON-MICRO

DMF 49371983

DIOSYNTH BVInactiveDEXAMETHASONE ACETATE MICRO AND NON MICRO

DMF 49441983

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDEXAMETHASONE

DMF 60301985

QUATRUMInactiveDEXAMETHASONE BASE BP/KUSP AS

DMF 62331986

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

Products (1)

#001 — 0.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

ELIXIR;ORAL | Approved: Jul 27, 1983

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

MODIFIEDStrength7/1/2026

Dexamethasone 0.5MG/5ML (NDA 088254) strength designation now includes Federal Register determination that the product was not discontinued or withdrawn for safety or effectiveness reasons.

Old: 0.5MG/5ML

New: 0.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**