Details for New Drug Application (NDA): 021162

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NDA 021162 describes MICARDIS HCT, 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 MICARDIS HCT profile page.

The generic ingredient in MICARDIS HCT is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.

Summary for 021162

Tradename:	MICARDIS HCT
Applicant:	Boehringer Ingelheim
Ingredient:	hydrochlorothiazide; telmisartan
Patents:	0

Pharmacology for NDA: 021162

Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 021162

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0042	0597-0042-37	3 BLISTER PACK in 1 CARTON (0597-0042-37) / 10 TABLET in 1 BLISTER PACK
MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0043	0597-0043-37	3 BLISTER PACK in 1 CARTON (0597-0043-37) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;40MG
Approval Date:	Nov 17, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG;80MG
Approval Date:	Nov 17, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG;80MG
Approval Date:	Apr 19, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021162

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-003	Apr 19, 2004	5,591,762	⤷ Get Started Free
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	5,591,762	⤷ Get Started Free
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	6,358,986	⤷ Get Started Free
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-002	Nov 17, 2000	5,591,762	⤷ Get Started Free
Boehringer Ingelheim	MICARDIS HCT	hydrochlorothiazide; telmisartan	TABLET;ORAL	021162-001	Nov 17, 2000	6,358,986	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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