← FDA Drug Approvals (Drugs@FDA)
FLUOXETINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS · Approved 2019-01-25
Drug application
- FDA Application #
ANDA211721
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FLUOXETINE HYDROCHLORIDE
- Generic name
- FLUOXETINE HYDROCHLORIDE
- Active ingredients
- FLUOXETINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- DR REDDYS
- Manufacturer
- NorthStar Rx LLC
- First approval
- 2019-01-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown