← FDA Drug Approvals (Drugs@FDA)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 1982-05-03
Drug application
- FDA Application #
ANDA087708- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Generic name
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Active ingredients
- ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HIKMA
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- First approval
- 1982-05-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown