← FDA DRUG APPROVALS

FDA NDA · NDA020729

UNIRETIC

Sponsor: UCB INC

APPLICATION
NDA020729
TYPE
NDA
ORIGINAL APPROVAL
1997-06-27
LATEST ACTION
2012-09-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

UNIRETICDiscontinued
HYDROCHLOROTHIAZIDE 25MG, MOEXIPRIL HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
UNIRETICDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, MOEXIPRIL HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
UNIRETICDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, MOEXIPRIL HYDROCHLORIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2012-09-13Labeling · Supplement 26 · unknown — Letter ↗AP
2012-01-19Labeling · Supplement 25 · unknown — Letter ↗AP
2011-08-23Labeling · Supplement 24 · unknown — Label ↗AP
2011-05-19Labeling · Supplement 23 · unknown — Label ↗AP
2010-01-13Labeling · Supplement 21 · unknown — Letter ↗AP
2003-10-29Labeling · Supplement 12 · standard — Letter ↗AP
2002-02-14Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
2001-09-24Manufacturing (CMC) · Supplement 9 · standardAP
2001-01-12Manufacturing (CMC) · Supplement 7 · standardAP
2000-12-22Manufacturing (CMC) · Supplement 8 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 6 · standardAP
2000-04-05Labeling · Supplement 5 · standardAP
1999-10-29Manufacturing (CMC) · Supplement 4 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 3 · standardAP
1998-01-21Labeling · Supplement 2 · standardAP
1997-11-18Manufacturing (CMC) · Supplement 1 · standardAP
1997-06-27Type 4 - New Combination · Original · standardAP
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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