← FDA Drug Approvals (Drugs@FDA)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2022-03-25
Drug application
- FDA Application #
ANDA215135- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- Generic name
- Acetaminophen
- Active ingredients
- ACETAMINOPHEN; BUTALBITAL; CAFFEINE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- HIKMA
- First approval
- 2022-03-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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