← FDA Drug Approvals (Drugs@FDA)
MONTELUKAST SODIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD V · Approved 2014-09-10
Drug application
- FDA Application #
ANDA202843- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- MONTELUKAST SODIUM
- Generic name
- MONTELUKAST
- Active ingredients
- MONTELUKAST SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HETERO LABS LTD V
- Manufacturer
- XLCare Pharmaceuticals Inc.
- First approval
- 2014-09-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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