← FDA Drug Approvals (Drugs@FDA)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: KV PHARM · Approved 1978-01-27
Drug application
- FDA Application #
ANDA085659- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Generic name
- Atropine Sulfate
- Active ingredients
- ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- KV PHARM
- First approval
- 1978-01-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown