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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 204195


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NDA 204195 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. Four suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.
Summary for 204195
Suppliers and Packaging for NDA: 204195
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ASPIRIN AND CAFFEINE aspirin; butalbital; caffeine TABLET;ORAL 204195 ANDA Vensun Pharmaceuticals, Inc. 42543-098 42543-098-01 100 TABLET in 1 BOTTLE, PLASTIC (42543-098-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Sep 22, 2016TE:RLD:No

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