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Details for New Drug Application (NDA): 019101

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NDA 019101 describes FENTANYL CITRATE PRESERVATIVE FREE, which is a drug marketed by Eurohlth Intl Sarl, Watson Labs Inc, and Hospira, and is included in three NDAs. It is available from two suppliers. Additional details are available on the FENTANYL CITRATE PRESERVATIVE FREE profile page.

The generic ingredient in FENTANYL CITRATE PRESERVATIVE FREE is fentanyl citrate. There are thirty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for NDA: 019101

Eurohlth Intl Sarl
fentanyl citrate
Therapeutic Class:Analgesics

Pharmacology for NDA: 019101

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 019101

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fentanyl citrate
INJECTABLE;INJECTION 019101 ANDA West-ward Pharmaceutical Corp. 0641-6024 0641-6024-10 10 AMPULE in 1 CARTON (0641-6024-10) > 2 mL in 1 AMPULE (0641-6024-01)
fentanyl citrate
INJECTABLE;INJECTION 019101 ANDA West-ward Pharmaceutical Corp. 0641-6025 0641-6025-10 10 AMPULE in 1 CARTON (0641-6025-10) > 5 mL in 1 AMPULE (0641-6025-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Jul 11, 1984TE:APRLD:Yes

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