← FDA DRUG APPROVALS

FDA NDA · NDA018303

LOPRESSOR HCT

Sponsor: VALIDUS PHARMS

APPLICATION
NDA018303
TYPE
NDA
ORIGINAL APPROVAL
1984-12-31
LATEST ACTION
2023-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

LOPRESSOR HCT · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 50MG, METOPROLOL TARTRATE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LOPRESSOR HCT · ReferencePrescription
HYDROCHLOROTHIAZIDE 25MG, METOPROLOL TARTRATE 50MG · TABLET · ORAL
LOPRESSOR HCT · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 25MG, METOPROLOL TARTRATE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2023-12-22Labeling · Supplement 42 · standard — Letter ↗AP
2022-05-03Labeling · Supplement 40 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 41 · standard — Label ↗AP
2011-03-15Labeling · Supplement 35 · unknown — Label ↗AP
2011-03-15Labeling · Supplement 36 · unknown — Label ↗AP
2009-08-07Labeling · Supplement 34 · standard — Letter ↗AP
2008-07-24Labeling · Supplement 33 · standard — Letter ↗AP
2008-01-08Labeling · Supplement 32 · standard — Label ↗AP
2006-09-07Labeling · Supplement 29 · standard — Letter ↗AP
2003-10-31Labeling · Supplement 25 · standard — Letter ↗AP
2002-06-14Manufacturing (CMC) · Supplement 24 · standardAP
2002-04-29Manufacturing (CMC) · Supplement 23 · standardAP
2002-02-08Manufacturing (CMC) · Supplement 22 · standardAP
2001-07-30Manufacturing (CMC) · Supplement 21 · standardAP
2000-05-12Manufacturing (CMC) · Supplement 19 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 20 · standardAP
1999-04-28Manufacturing (CMC) · Supplement 18 · standardAP
1999-02-18Manufacturing (CMC) · Supplement 17 · standardAP
1997-11-07Labeling · Supplement 16 · standardAP
1997-01-08Manufacturing (CMC) · Supplement 15 · standardAP
1996-06-07Manufacturing (CMC) · Supplement 14 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 13 · standardAP
1995-07-31Manufacturing (CMC) · Supplement 12 · standardAP
1995-02-02Labeling · Supplement 11 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 10 · standardAP
1991-09-18Labeling · Supplement 9AP
1990-06-14Labeling · Supplement 8AP
1988-12-09Manufacturing (CMC) · Supplement 6 · standardAP
1988-09-23Labeling · Supplement 5AP
1988-05-31Manufacturing (CMC) · Supplement 4 · standardAP
1985-10-23Manufacturing (CMC) · Supplement 3 · standardAP
1985-03-26Manufacturing (CMC) · Supplement 1 · standardAP
1985-02-22Labeling · Supplement 2AP
1984-12-31Type 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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