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Last Updated: December 21, 2024

Details for New Drug Application (NDA): 085441


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NDA 085441 describes BUTALBITAL, ASPIRIN AND CAFFEINE, which is a drug marketed by Lgm Pharma, Nostrum Labs Inc, Watson Labs, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, Puracap Pharm, Quantum Pharmics, and Strides Pharma, and is included in twelve NDAs. It is available from two suppliers. Additional details are available on the BUTALBITAL, ASPIRIN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ASPIRIN AND CAFFEINE is aspirin; butalbital; caffeine. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.
Summary for 085441

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Oct 31, 1984TE:RLD:No

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