← FDA DRUG APPROVALS

FDA NDA · NDA019815

PROAMATINE

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA019815
TYPE
NDA
ORIGINAL APPROVAL
1996-09-06
LATEST ACTION
2017-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROAMATINE · ReferenceDiscontinued
MIDODRINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PROAMATINE · ReferenceDiscontinued
MIDODRINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PROAMATINE · ReferenceDiscontinued
MIDODRINE HYDROCHLORIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2017-02-07Labeling · Supplement 10 · standard — Label ↗AP
2004-07-22Labeling · Supplement 7 · standard — Letter ↗AP
2002-03-20Manufacturing (CMC) · Supplement 5 · priority — Review ↗AP
2002-02-22Manufacturing (CMC) · Supplement 6 · priorityAP
2000-05-24Manufacturing (CMC) · Supplement 4 · priorityAP
1999-01-29Manufacturing (CMC) · Supplement 2 · priorityAP
1999-01-28Manufacturing (CMC) · Supplement 3 · priorityAP
1997-05-16Manufacturing (CMC) · Supplement 1 · priorityAP
1996-09-06Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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