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Details for New Drug Application (NDA): 086162

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NDA 086162 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, Pharmaceutics Intl, 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. Sixteen suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.

Summary for NDA: 086162

Tradename:
BUTALBITAL, ASPIRIN AND CAFFEINE
Applicant:
Hikma Intl Pharms
Ingredient:
aspirin; butalbital; caffeine
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 0143-1785-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-1785-01)
BUTALBITAL, ASPIRIN AND CAFFEINE
aspirin; butalbital; caffeine
TABLET;ORAL 086162 ANDA West-ward Pharmaceutical Corp 0143-1785 0143-1785-05 500 TABLET in 1 BOTTLE, PLASTIC (0143-1785-05)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Feb 16, 1984TE:AARLD:Yes


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