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Details for New Drug Application (NDA): 075759

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NDA 075759 describes BUTORPHANOL TARTRATE, which is a drug marketed by Hikma Farmaceutica, Roxane, Hospira, Eurohlth Intl Sarl, Mylan, Claris, and Apotex Inc, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the BUTORPHANOL TARTRATE profile page.

The generic ingredient in BUTORPHANOL TARTRATE is butorphanol tartrate. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.

Summary for NDA: 075759

butorphanol tartrate
Therapeutic Class:Analgesics

Pharmacology for NDA: 075759

Suppliers and Packaging for NDA: 075759

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
butorphanol tartrate
SPRAY, METERED;NASAL 075759 ANDA Mylan Pharmaceuticals Inc. 0378-9639 0378-9639-43 2.5 mL in 1 VIAL, MULTI-DOSE (0378-9639-43)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength1MG/SPRAY
Approval Date:Aug 8, 2001TE:ABRLD:Yes

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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.