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Generated: May 25, 2017

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Details for New Drug Application (NDA): 074413

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NDA 074413 describes SUFENTANIL CITRATE, which is a drug marketed by Watson Labs, West-ward Pharms Int, and Hospira, and is included in three NDAs. It is available from two suppliers. Additional details are available on the SUFENTANIL CITRATE profile page.

The generic ingredient in SUFENTANIL CITRATE is sufentanil citrate. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.

Summary for NDA: 074413

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 074413

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 074413

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sufentanil citrate
INJECTABLE;INJECTION 074413 ANDA West-ward Pharmaceutical Corp. 0641-6110 0641-6110-10 10 AMPULE in 1 CARTON (0641-6110-10) > 1 mL in 1 AMPULE (0641-6110-01)
sufentanil citrate
INJECTABLE;INJECTION 074413 ANDA West-ward Pharmaceutical Corp. 0641-6111 0641-6111-10 10 AMPULE in 1 CARTON (0641-6111-10) > 2 mL in 1 AMPULE (0641-6111-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Dec 15, 1995TE:APRLD:No

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