← FDA Drug Approvals (Drugs@FDA)
BUTALBITAL AND ACETAMINOPHEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LGM PHARMA · Approved 2011-08-23
Drug application
- FDA Application #
ANDA090956
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUTALBITAL AND ACETAMINOPHEN
- Generic name
- BUTALBITAL AND ACETAMINOPHEN TABLETS
- Active ingredients
- ACETAMINOPHEN; BUTALBITAL
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- LGM PHARMA
- Manufacturer
- Oceanside Pharmaceuticals
- First approval
- 2011-08-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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