← FDA Drug Approvals (Drugs@FDA)
LABETALOL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2017-09-19
Drug application
- FDA Application #
ANDA207743- 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
- ZYDUS PHARMS
- Manufacturer
- BluePoint Laboratories Inc.
- First approval
- 2017-09-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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