← FDA DRUG APPROVALS

FDA NDA · NDA020727

BIDIL

hydralazine hydrochloride and isosorbide dinitrate

Sponsor: AZURITY

APPLICATION
NDA020727
TYPE
NDA
ORIGINAL APPROVAL
2005-06-23
LATEST ACTION
2021-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BIDIL · ReferencePrescription
HYDRALAZINE HYDROCHLORIDE 37.5MG, ISOSORBIDE DINITRATE 20MG · TABLET · ORAL

Approval history

2021-01-13Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2019-03-12Labeling · Supplement 10 · standard — Label ↗AP
2016-06-14Manufacturing (CMC) · Supplement 6 · standardAP
2015-04-02Labeling · Supplement 5 · standard — Letter ↗AP
2013-03-27Labeling · Supplement 4 · unknown — Label ↗AP
2005-06-23Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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