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SIMVASTATIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2014-11-25

Drug application

FDA Application #
ANDA200895
Application type
Abbreviated New Drug Application (Generic)
Brand name
SIMVASTATIN
Generic name
SIMVASTATIN
Active ingredients
SIMVASTATIN
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
HETERO LABS LTD III
Manufacturer
XLCare Pharmaceuticals Inc.
First approval
2014-11-25

Source

Authoritative
Drugs@FDA application overview
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