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NALTREXONE HYDROCHLORIDE

ANDA

NALTREXONE HYDROCHLORIDE | A075434 | NOVITIUM PHARMA LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs

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

ASPEN OSS BVNALTREXONE HYDROCHLORIDE

DMF 151022000

FRANCOPIA A EUROAPI CONALTREXONE HYDROCHLORIDE

DMF 206232007

SUN PHARMACEUTICAL INDUSTRIES LTDNALTREXONE HYDROCHLORIDE USP (DIHYDRATE FORM)

DMF 212172007

MACFARLAN SMITH LTDNALTREXONE HYDROCHLORIDE

DMF 215902008

SIEGFRIED LTDNALTREXONE HYDROCHLORIDE

DMF 232142009

NORAMCO LLCNALTREXONE HYDROCHLORIDE DRUG SUBSTANCE

DMF 233252009

SUN PHARMACEUTICAL INDUSTRIES LTDNALTREXONE HYDROCHLORIDE USP (DIHYDRATE FORM) (PROCESS-II)

DMF 365602022

SANECA PHARMACEUTICALS ASNALTREXONE HYDROCHLORIDE

DMF 412642025

STHREE CHEMICALS PRIVATE LTDNALTREXONE HYDROCHLORIDE USP

DMF 424342025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 8, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 8, 2000

No patent or exclusivity listings for this strength.