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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 075824


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NDA 075824 describes BUTORPHANOL TARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apotex, and Rising, and is included in fourteen NDAs. It is available from three suppliers. Additional details are available on the BUTORPHANOL TARTRATE profile page.

The generic ingredient in BUTORPHANOL TARTRATE 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 075824
Tradename:BUTORPHANOL TARTRATE
Applicant:Hikma
Ingredient:butorphanol tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075824
Medical Subject Heading (MeSH) Categories for 075824
Suppliers and Packaging for NDA: 075824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTORPHANOL TARTRATE butorphanol tartrate SPRAY, METERED;NASAL 075824 ANDA Hikma Pharmaceuticals USA Inc. 0054-3090 0054-3090-36 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) / 2.5 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength1MG/SPRAY
Approval Date:Mar 12, 2002TE:ABRLD:No

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