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DANTROLENE SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS · Approved 2005-03-01

Drug application

FDA Application #
ANDA076856
Application type
Abbreviated New Drug Application (Generic)
Brand name
DANTROLENE SODIUM
Generic name
DANTROLENE SODIUM
Active ingredients
DANTROLENE SODIUM
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
IMPAX LABS
Manufacturer
Amneal Pharmaceuticals of New York LLC
First approval
2005-03-01

Source

Authoritative
Drugs@FDA application overview
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