← FDA Drug Approvals (Drugs@FDA)
LABETALOL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CAPLIN · Approved 2021-09-07
Drug application
- FDA Application #
ANDA214533
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LABETALOL HYDROCHLORIDE
- Generic name
- LABETALOL HYDROCHLORIDE
- Active ingredients
- LABETALOL HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- CAPLIN
- Manufacturer
- Caplin Steriles Limited
- First approval
- 2021-09-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown