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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 074626


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NDA 074626 describes BUTORPHANOL TARTRATE PRESERVATIVE FREE, which is a drug marketed by Baxter Hlthcare Corp, Hikma, and Hospira, and is included in five NDAs. It is available from one supplier. Additional details are available on the BUTORPHANOL TARTRATE PRESERVATIVE FREE profile page.

The generic ingredient in BUTORPHANOL TARTRATE PRESERVATIVE FREE is butorphanol tartrate. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.
Summary for 074626
Tradename:BUTORPHANOL TARTRATE PRESERVATIVE FREE
Applicant:Hospira
Ingredient:butorphanol tartrate
Patents:0
Pharmacology for NDA: 074626
Medical Subject Heading (MeSH) Categories for 074626
Suppliers and Packaging for NDA: 074626
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTORPHANOL TARTRATE PRESERVATIVE FREE butorphanol tartrate INJECTABLE;INJECTION 074626 ANDA Hospira, Inc. 0409-1623 0409-1623-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1623-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1623-21)
BUTORPHANOL TARTRATE PRESERVATIVE FREE butorphanol tartrate INJECTABLE;INJECTION 074626 ANDA Hospira, Inc. 0409-1626 0409-1626-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Jan 23, 1997TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Jan 23, 1997TE:APRLD:No

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