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Details for New Drug Application (NDA): 016194

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NDA 016194 describes TALWIN, which is a drug marketed by Hospira and Sanofi Aventis Us and is included in four NDAs. It is available from two suppliers. Additional details are available on the TALWIN profile page.

The generic ingredient in TALWIN 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: 016194

pentazocine lactate
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 016194

Suppliers and Packaging for NDA: 016194

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
pentazocine lactate
INJECTABLE;INJECTION 016194 NDA Hospira, Inc. 0409-1920 0409-1920-10 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1920-10) > 10 mL in 1 VIAL, MULTI-DOSE
pentazocine lactate
INJECTABLE;INJECTION 016194 NDA Hospira, Inc. 0409-1941 0409-1941-01 5 TRAY in 1 CARTON (0409-1941-01) > 5 AMPULE in 1 TRAY > 1 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 30MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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