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MEXILETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANNORA PHARMA · Approved 2022-11-09

Drug application

FDA Application #
ANDA216463
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
ANNORA PHARMA
Manufacturer
Camber Pharmaceuticals, Inc.
First approval
2022-11-09

Source

Authoritative
Drugs@FDA application overview
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