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Details for New Drug Application (NDA): 072786

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NDA 072786 describes FENTANYL CITRATE PRESERVATIVE FREE, which is a drug marketed by West-ward Pharms Int, 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: 072786

Tradename:
FENTANYL CITRATE PRESERVATIVE FREE
Applicant:
Hospira
Ingredient:
fentanyl citrate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 072786

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 072786

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL CITRATE PRESERVATIVE FREE
fentanyl citrate
INJECTABLE;INJECTION 072786 ANDA Hospira, Inc. 0409-1276 0409-1276-32 10 CARTRIDGE in 1 CARTON (0409-1276-32) > 2 mL in 1 CARTRIDGE (0409-1276-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Sep 24, 1991TE:APRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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