Details for New Drug Application (NDA): 022401

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NDA 022401 describes TWYNSTA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. Additional details are available on the TWYNSTA profile page.

The generic ingredient in TWYNSTA is amlodipine besylate; telmisartan. There are fifty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amlodipine besylate; telmisartan profile page.

Summary for 022401

Tradename:	TWYNSTA
Applicant:	Boehringer Ingelheim
Ingredient:	amlodipine besylate; telmisartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 16, 2009	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 16, 2009	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 16, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022401

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-001	Oct 16, 2009	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-004	Oct 16, 2009	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-002	Oct 16, 2009	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	TWYNSTA	amlodipine besylate; telmisartan	TABLET;ORAL	022401-003	Oct 16, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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