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NALTREXONE HYDROCHLORIDE

ANDA

NALTREXONE HYDROCHLORIDE | A076264 | SPECGX LLC

3 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5194 Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, suitable for an ANDA, with the 50 mg	Suitability	2026-05-11	Open	Hyman

Source: Regulations.gov. FDA citizen petitions matched by application number.

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
Apr 11, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 22, 2002

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 22, 2002

#003 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 22, 2002