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METHYLPHENIDATE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2015-11-13

Drug application

FDA Application #
ANDA207884
Application type
Abbreviated New Drug Application (Generic)
Brand name
METHYLPHENIDATE HYDROCHLORIDE
Generic name
METHYLPHENIDATE HYDROCHLORIDE
Active ingredients
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
NOVEL LABS INC
Manufacturer
Lupin Pharmaceuticals,Inc.
First approval
2015-11-13

Source

Authoritative
Drugs@FDA application overview
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