← FDA Drug Approvals (Drugs@FDA)
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ABLE · Approved 2003-08-21
Drug application
- FDA Application #
ANDA076528- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
- Generic name
- Butalbital
- Active ingredients
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
- Dosage form
- Capsule
- Route
- Oral
- Marketing status
- Prescription
- Sponsor
- ABLE
- First approval
- 2003-08-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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