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Details for New Drug Application (NDA): 089718

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NDA 089718 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Sun Pharm Inds, Mallinckrodt, Mayne Pharma Inc, Vintage Pharms, Hikma Pharms Llc, Gilbert Labs, Watson Labs, Graham Dm, Lannett Holdings Inc, Ingenus Pharms Nj, Mikart, Mirror Pharms Llc, Nexgen Pharma, and Able, and is included in twenty-four NDAs. It is available from forty-five suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-five drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.

Summary for NDA: 089718

Pharmacology for NDA: 089718

Suppliers and Packaging for NDA: 089718

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; butalbital; caffeine
TABLET;ORAL 089718 ANDA West-Ward Pharmaceuticals Corp 0143-1787 0143-1787-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-1787-01)
acetaminophen; butalbital; caffeine
TABLET;ORAL 089718 ANDA West-Ward Pharmaceuticals Corp 0143-1787 0143-1787-05 500 TABLET in 1 BOTTLE, PLASTIC (0143-1787-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;50MG;40MG
Approval Date:Jun 12, 1995TE:AARLD:No

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