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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022021
Company: KING PFIZER

Other Important Information from FDA

Products on NDA 022021

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALTACE	RAMIPRIL	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ALTACE	RAMIPRIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ALTACE	RAMIPRIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ALTACE	RAMIPRIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022021

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2007	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022021s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022021TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2012	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022021s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022021s008ltr.pdf
08/04/2011	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022021s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022021s007ltr.pdf
11/20/2009	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022021s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022021s006ltr.pdf
02/09/2009	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s054,022021s005ltr.pdf
03/04/2009	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019901s052,022021s001ltr.pdf

Labels for NDA 022021

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2012	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022021s008lbl.pdf
08/04/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022021s007lbl.pdf
11/20/2009	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022021s006lbl.pdf
02/27/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022021lbl.pdf

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