← 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