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DICYCLOMINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2025-06-06
Drug application
- FDA Application #
ANDA218310- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DICYCLOMINE HYDROCHLORIDE
- Generic name
- Dicyclomine Hydrochloride
- Active ingredients
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PRINSTON INC
- First approval
- 2025-06-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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