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Details for New Drug Application (NDA): 040387

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NDA 040387 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Sun Pharm Inds, Mallinckrodt, Mayne Pharma Inc, Vintage Pharms, Nuvo Pharm Inc, 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-five 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: 040387

Tradename:
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Applicant:
Mikart
Ingredient:
acetaminophen; butalbital; caffeine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040387

Suppliers and Packaging for NDA: 040387

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
acetaminophen; butalbital; caffeine
SOLUTION;ORAL 040387 ANDA Mikart, Inc. 46672-633 46672-633-01 30 mL in 1 BOTTLE, PLASTIC (46672-633-01)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
acetaminophen; butalbital; caffeine
SOLUTION;ORAL 040387 ANDA Mikart, Inc. 46672-633 46672-633-16 473 mL in 1 BOTTLE, PLASTIC (46672-633-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength325MG/15ML;50MG/15ML;40MG/15ML
Approval Date:Jan 31, 2003TE:RLD:Yes


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