← FDA Drug Approvals (Drugs@FDA)
DICYCLOMINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PRINSTON INC · Approved 2023-08-30
Drug application
- FDA Application #
ANDA217531- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DICYCLOMINE HYDROCHLORIDE
- Generic name
- DICYCLOMINE HYDROCHLORIDE
- Active ingredients
- DICYCLOMINE HYDROCHLORIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PRINSTON INC
- Manufacturer
- Solco Healthcare US,LLC
- First approval
- 2023-08-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown