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FDA ANDA · ANDA076449

MIDODRINE HYDROCHLORIDE

Sponsor: IMPAX PHARMS

APPLICATION
ANDA076449
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-27
LATEST ACTION
2019-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MIDODRINE HYDROCHLORIDEDiscontinued
MIDODRINE HYDROCHLORIDE 10MG · TABLET · ORAL
MIDODRINE HYDROCHLORIDEDiscontinued
MIDODRINE HYDROCHLORIDE 2.5MG · TABLET · ORAL
MIDODRINE HYDROCHLORIDEDiscontinued
MIDODRINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2019-11-13Labeling · Supplement 14 · standardAP
2005-12-16Labeling · Supplement 1AP
2004-05-27OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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