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ISOSORBIDE DINITRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 1987-10-02

Drug application

FDA Application #
ANDA087537
Application type
Abbreviated New Drug Application (Generic)
Brand name
ISOSORBIDE DINITRATE
Generic name
ISOSORBIDE DINITRATE
Active ingredients
ISOSORBIDE DINITRATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
PH HEALTH
Manufacturer
Endo USA, Inc.
First approval
1987-10-02

Source

Authoritative
Drugs@FDA application overview
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