← FDA Drug Approvals (Drugs@FDA)
LABETALOL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANDAS 5 HOLDING · Approved 1999-07-29
Drug application
- FDA Application #
ANDA075215- 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
- ANDAS 5 HOLDING
- Manufacturer
- Method Pharmaceuticals, LLC
- First approval
- 1999-07-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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