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Details for New Drug Application (NDA): 074736

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NDA 074736 describes NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, which is a drug marketed by Sun Pharm Inds Ltd, Gavis Pharms, and Watson Labs, and is included in three NDAs. It is available from nine suppliers. Additional details are available on the NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE profile page.

The generic ingredient in NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

Summary for NDA: 074736

Suppliers and Packaging for NDA: 074736

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
naloxone hydrochloride; pentazocine hydrochloride
TABLET;ORAL 074736 ANDA Actavis Pharma, Inc. 0591-0395 0591-0395-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
naloxone hydrochloride; pentazocine hydrochloride
TABLET;ORAL 074736 ANDA STAT RX USA LLC 16590-556 16590-556-30 30 TABLET in 1 BOTTLE (16590-556-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE;EQ 50MG BASE
Approval Date:Jan 21, 1997TE:ABRLD:Yes


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