← FDA Drug Approvals (Drugs@FDA)
DARIFENACIN HYDROBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PURACAP LABS BLU · Approved 2020-01-06
Drug application
- FDA Application #
ANDA211045
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DARIFENACIN HYDROBROMIDE
- Generic name
- DARIFENACIN HYDROBROMIDE
- Active ingredients
- DARIFENACIN HYDROBROMIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PURACAP LABS BLU
- Manufacturer
- POLYGEN PHARMACEUTICALS INC.
- First approval
- 2020-01-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown