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MEXILETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SENORES PHARMS · Approved 2021-10-01

Drug application

FDA Application #
ANDA214089
Application type
Abbreviated New Drug Application (Generic)
Brand name
MEXILETINE HYDROCHLORIDE
Generic name
MEXILETINE HYDROCHLORIDE
Active ingredients
MEXILETINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
SENORES PHARMS
Manufacturer
Sun Pharmaceutical Industries, Inc.
First approval
2021-10-01

Source

Authoritative
Drugs@FDA application overview
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