← FDA DRUG APPROVALS

FDA NDA · NDA018031

INDERIDE-40/25

Sponsor: WYETH PHARMS INC

APPLICATION
NDA018031
TYPE
NDA
ORIGINAL APPROVAL
1979-06-15
LATEST ACTION
2011-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

INDERIDE-40/25 · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 25MG, PROPRANOLOL HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
INDERIDE-80/25 · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 25MG, PROPRANOLOL HYDROCHLORIDE 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2011-03-17Labeling · Supplement 38 · unknown — Letter ↗AP
2011-03-17Labeling · Supplement 37 · unknown — Letter ↗AP
2010-03-04Labeling · Supplement 36 · unknown — Label ↗AP
2008-01-02Labeling · Supplement 35 · standard — Label ↗AP
2007-02-21Labeling · Supplement 34 · standard — Letter ↗AP
2006-12-29Labeling · Supplement 33 · standard — Letter ↗AP
2004-06-09Labeling · Supplement 32 · standard — Letter ↗AP
2001-11-01Labeling · Supplement 30 · standardAP
2001-05-03Labeling · Supplement 31 · standardAP
1997-11-07Labeling · Supplement 29 · standardAP
1994-06-14Manufacturing (CMC) · Supplement 28 · standardAP
1990-02-08Labeling · Supplement 17AP
1990-02-08Efficacy · Supplement 18AP
1989-08-09Manufacturing (CMC) · Supplement 27 · standardAP
1989-07-10Manufacturing (CMC) · Supplement 25 · standardAP
1989-04-12Manufacturing (CMC) · Supplement 26 · standardAP
1988-11-07Labeling · Supplement 24AP
1988-05-25Manufacturing (CMC) · Supplement 23 · standardAP
1986-12-30Manufacturing (CMC) · Supplement 22 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 19 · standardAP
1985-02-22Manufacturing (CMC) · Supplement 16 · standardAP
1983-08-11Manufacturing (CMC) · Supplement 15 · standardAP
1982-08-23Manufacturing (CMC) · Supplement 13 · standardAP
1982-06-09Manufacturing (CMC) · Supplement 12 · standardAP
1982-04-28Labeling · Supplement 11AP
1982-04-12Manufacturing (CMC) · Supplement 7 · standardAP
1982-03-03Manufacturing (CMC) · Supplement 9 · standardAP
1982-01-26Manufacturing (CMC) · Supplement 10 · standardAP
1981-12-10Manufacturing (CMC) · Supplement 2 · standardAP
1981-01-27Manufacturing (CMC) · Supplement 6 · standardAP
1980-10-03Manufacturing (CMC) · Supplement 5 · standardAP
1980-09-19Manufacturing (CMC) · Supplement 8 · standardAP
1980-05-28Manufacturing (CMC) · Supplement 3 · standardAP
1980-03-27Manufacturing (CMC) · Supplement 4 · standardAP
1979-07-31Manufacturing (CMC) · Supplement 1 · standardAP
1979-06-15Type 4 - New Combination · Original · standardAP
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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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