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Generated: April 19, 2019

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Details for New Drug Application (NDA): 075045

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NDA 075045 describes BUTORPHANOL TARTRATE PRESERVATIVE FREE, which is a drug marketed by Baxter Hlthcare Corp, Hospira, and West-ward Pharms Int, 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. Five suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.
Summary for 075045
Applicant:West-ward Pharms Int
Ingredient:butorphanol tartrate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075045

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Aug 12, 1998TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Aug 12, 1998TE:APRLD:No

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