← FDA Drug Approvals (Drugs@FDA)
LABETALOL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CADILA PHARMS LTD · Approved 2019-05-13
Drug application
- FDA Application #
ANDA211325- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LABETALOL HYDROCHLORIDE
- Generic name
- LABETALOL HYDROCHLORIDE
- Active ingredients
- LABETALOL HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- CADILA PHARMS LTD
- Manufacturer
- Cadila Pharmaceuticals Limited
- First approval
- 2019-05-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown