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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075735


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NDA 075735 describes NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, which is a drug marketed by Lupin, Sun Pharm Inds Ltd, and Watson Labs, and is included in three NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.
Pharmacology for NDA: 075735
Suppliers and Packaging for NDA: 075735
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 075735 ANDA Lupin Pharmaceuticals,Inc. 43386-680 43386-680-01 100 TABLET in 1 BOTTLE (43386-680-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG BASE;EQ 50MG BASE
Approval Date:Jul 11, 2001TE:ABRLD:No

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