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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 090356

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NDA 090356 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Barr, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the NALTREXONE HYDROCHLORIDE profile page.

The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.
Summary for 090356
Applicant:Sun Pharm
Ingredient:naltrexone hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 090356
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 090356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 090356 ANDA Major Pharmaceuticals 0904-7036 0904-7036-04 30 BLISTER PACK in 1 CARTON (0904-7036-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 090356 ANDA Sun Pharmaceutical Industries, Inc. 47335-326 47335-326-08 100 TABLET, FILM COATED in 1 BOTTLE (47335-326-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Feb 24, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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