← FDA Drug Approvals (Drugs@FDA)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GENUS · Approved 2003-01-31
Drug application
- FDA Application #
ANDA040387- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Generic name
- BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
- Active ingredients
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- Dosage form
- SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GENUS
- Manufacturer
- Genus Lifesciences Inc.
- First approval
- 2003-01-31
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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