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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. It is available from one supplier. Additional details are available on the TWYNSTA profile page.

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

Summary for NDA: 022401

Tradename:
TWYNSTA
Applicant:
Boehringer Ingelheim
Ingredient:
amlodipine besylate; telmisartan
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 022401

Suppliers and Packaging for NDA: 022401

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL 022401 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0124 0597-0124-37 3 BLISTER PACK in 1 CARTON (0597-0124-37) > 10 TABLET, MULTILAYER in 1 BLISTER PACK
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL 022401 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0125 0597-0125-37 3 BLISTER PACK in 1 CARTON (0597-0125-37) > 10 TABLET, MULTILAYER in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;40MG
Approval Date:Oct 16, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE;40MG
Approval Date:Oct 16, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;80MG
Approval Date:Oct 16, 2009TE:ABRLD:No

Expired Orange Book Patents for NDA: 022401

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL022401-001Oct 16, 20095,591,762► subscribe
Boehringer Ingelheim
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL022401-004Oct 16, 20095,591,762► subscribe
Boehringer Ingelheim
TWYNSTA
amlodipine besylate; telmisartan
TABLET;ORAL022401-002Oct 16, 20095,591,762► subscribe
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