← FDA Drug Approvals (Drugs@FDA)
LEVALBUTEROL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN SPECIALITY LP · Approved 2009-03-20
Drug application
- FDA Application #
ANDA078309
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LEVALBUTEROL HYDROCHLORIDE
- Generic name
- LEVALBUTEROL
- Active ingredients
- LEVALBUTEROL HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- INHALATION
- Marketing status
- Prescription
- Sponsor
- MYLAN SPECIALITY LP
- Manufacturer
- Mylan Pharmaceuticals Inc.
- First approval
- 2009-03-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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