FDA NDA · NDA022021

ALTACE

Sponsor: KING PFIZER

APPLICATION

NDA022021

TYPE

NDA

ORIGINAL APPROVAL

2007-02-27

LATEST ACTION

2012-01-18

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

ALTACE · ReferenceDiscontinued

RAMIPRIL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

ALTACE · ReferenceDiscontinued

RAMIPRIL 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

ALTACE · ReferenceDiscontinued

RAMIPRIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

ALTACE · ReferenceDiscontinued

RAMIPRIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

2012-01-18Labeling · Supplement 8 · standard — Letter ↗AP

2011-08-04Labeling · Supplement 7 · standard — Letter ↗AP

2009-11-20Labeling · Supplement 6 · standard — Label ↗AP

2009-03-04Labeling · Supplement 1 · standard — Letter ↗AP

2009-02-09Labeling · Supplement 5 · standard — Letter ↗AP

2007-02-27Type 3 - New Dosage Form · Original · standard — Label ↗AP

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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