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DICYCLOMINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TWI PHARMS · Approved 2023-06-01
Drug application
- FDA Application #
ANDA216782- 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
- TWI PHARMS
- Manufacturer
- Upsher-Smith Laboratories, LLC
- First approval
- 2023-06-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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