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DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UNICHEM · Approved 2018-11-13
Drug application
- FDA Application #
ANDA210819- 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
- UNICHEM
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- First approval
- 2018-11-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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