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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086162

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NDA 086162 describes BUTALBITAL, ASPIRIN AND CAFFEINE, which is a drug marketed by Nostrum Labs Inc, Watson Labs, Actavis Elizabeth, Halsey, Hikma Intl Pharms, Ivax Pharms, PII, Puracap Pharm, Quantum Pharmics, 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 086162

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

Suppliers and Packaging for NDA: 086162

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ASPIRIN AND CAFFEINE aspirin; butalbital; caffeine TABLET;ORAL 086162 ANDA West-ward Pharmaceutical Corp 0143-1785 0143-1785-50 50 TABLET in 1 BOTTLE, PLASTIC (0143-1785-50)
BUTALBITAL, ASPIRIN AND CAFFEINE aspirin; butalbital; caffeine TABLET;ORAL 086162 ANDA West-ward Pharmaceutical Corp 0143-1785 0143-1785-10 1000 TABLET in 1 BOTTLE, PLASTIC (0143-1785-10)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Feb 16, 1984TE:AARLD:No


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