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METHYLPHENIDATE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2020-10-06

Drug application

FDA Application #
ANDA212288
Application type
Abbreviated New Drug Application (Generic)
Brand name
METHYLPHENIDATE HYDROCHLORIDE
Generic name
Methylphenidate Hydrochloride
Active ingredients
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
ALKEM LABS LTD
First approval
2020-10-06

Source

Authoritative
Drugs@FDA application overview
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