Viewing data from:

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

ANDA

DEXAMETHASONE SODIUM PHOSPHATE | A040491 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs5 inactive

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

EUROAPI FRANCEDEXAMETHASONE SODIUM PHOSPHATE

DMF 39631980

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

DMF 65251986

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDDEXAMETHASONE SODIUM PHOSPHATE

DMF 242152010

CURIA SPAIN SAUDEXAMETHASONE SODIUM PHOSPHATE

DMF 294122015

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 362692022

HENAN LIHUA PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 392592024

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 417282025

SYMBIOTEC PHARMALAB PRIVATE LIMITEDDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 424652025

DIOSYNTH BVInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 38411980

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 59711985

QUATRUMInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 72251987

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 226472008

TIANJIN TIANYAO PHARMACEUTICALS CO LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 271952013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 28, 2015	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG PHOSPHATE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Apr 11, 2003

No patent or exclusivity listings for this strength.