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Last Updated: April 27, 2024

Details for New Drug Application (NDA): 022021

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NDA 022021 describes ALTACE, which is a drug marketed by King Pharms Llc and King Pfizer and is included in two NDAs. It is available from one supplier. Additional details are available on the ALTACE profile page.

The generic ingredient in ALTACE is ramipril. There are nineteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ramipril profile page.

Summary for 022021

Tradename:	ALTACE
Applicant:	King Pfizer
Ingredient:	ramipril
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 022021

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 27, 2007	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 27, 2007	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 27, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 022021

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007	⤷ Try a Trial	⤷ Try a Trial
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-003	Feb 27, 2007	⤷ Try a Trial	⤷ Try a Trial
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-001	Feb 27, 2007	⤷ Try a Trial	⤷ Try a Trial
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-002	Feb 27, 2007	⤷ Try a Trial	⤷ Try a Trial
King Pfizer	ALTACE	ramipril	TABLET;ORAL	022021-001	Feb 27, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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