← FDA Drug Approvals (Drugs@FDA)
ROSUVASTATIN CALCIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLENMARK SPECLT · Approved 2016-07-19
Drug application
- FDA Application #
ANDA079172- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ROSUVASTATIN CALCIUM
- Generic name
- ROSUVASTATIN CALCIUM
- Active ingredients
- ROSUVASTATIN CALCIUM
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GLENMARK SPECLT
- Manufacturer
- Glenmark Pharmaceutials Inc., USA
- First approval
- 2016-07-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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