← FDA Drug Approvals (Drugs@FDA)
TERBUTALINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS · Approved 2001-06-26
Drug application
- FDA Application #
ANDA075877- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- TERBUTALINE SULFATE
- Generic name
- TERBUTALINE SULFATE
- Active ingredients
- TERBUTALINE SULFATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- IMPAX LABS
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- First approval
- 2001-06-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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