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LABETALOL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2012-07-10

Drug application

FDA Application #
ANDA200908
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
PH HEALTH
First approval
2012-07-10

Source

Authoritative
Drugs@FDA application overview
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