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Details for New Drug Application (NDA): 074918

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NDA 074918 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Barr, Sandoz, Sun Pharma Global, Mallinckrodt, and Elite Labs, and is included in six NDAs. It is available from thirteen suppliers. Additional details are available on the NALTREXONE HYDROCHLORIDE profile page.

The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are seventeen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

Summary for NDA: 074918

Pharmacology for NDA: 074918

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 074918

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naltrexone hydrochloride
TABLET;ORAL 074918 ANDA Barr Laboratories Inc. 0555-0902 0555-0902-01 30 TABLET, FILM COATED in 1 BOTTLE (0555-0902-01)
naltrexone hydrochloride
TABLET;ORAL 074918 ANDA Barr Laboratories Inc. 0555-0902 0555-0902-02 100 TABLET, FILM COATED in 1 BOTTLE (0555-0902-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 8, 1998TE:ABRLD:No

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