← FDA Drug Approvals (Drugs@FDA)
BENTYL
NDA · New Drug Application · Sponsor: APTALIS PHARMA US · Approved 1951-04-30
Drug application
- FDA Application #
NDA007961- Application type
- New Drug Application
- Brand name
- BENTYL
- Generic name
- Dicyclomine Hydrochloride
- Active ingredients
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- APTALIS PHARMA US
- First approval
- 1951-04-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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