← FDA Drug Approvals (Drugs@FDA)
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: WINDER LABS LLC · Approved 2021-01-27
Drug application
- FDA Application #
ANDA211362- 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
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- WINDER LABS LLC
- Manufacturer
- Winder Laboratories LLC
- First approval
- 2021-01-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown