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ISOSORBIDE MONONITRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2022-11-07

Drug application

FDA Application #
ANDA216557
Application type
Abbreviated New Drug Application (Generic)
Brand name
ISOSORBIDE MONONITRATE
Generic name
ISOSORBIDE MONONITRATE
Active ingredients
ISOSORBIDE MONONITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
AUROBINDO PHARMA
Manufacturer
Aurobindo Pharma Limited
First approval
2022-11-07

Source

Authoritative
Drugs@FDA application overview
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