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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204195

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NDA 204195 describes BUTALBITAL, ASPIRIN AND CAFFEINE, which is a drug marketed by Actavis Elizabeth, Watson Labs, Ivax Pharms, Halsey, Puracap Pharm, Nostrum Labs Inc, Hikma Intl Pharms, Quantum Pharmics, PII, and Sandoz, and is included in eleven NDAs. It is available from nine 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-one drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.

Summary for NDA: 204195

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

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)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
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