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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 020850

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NDA 020850 describes MICARDIS, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. Additional details are available on the MICARDIS profile page.

The generic ingredient in MICARDIS 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 020850

Tradename:	MICARDIS
Applicant:	Boehringer Ingelheim
Ingredient:	telmisartan
Patents:	0

Pharmacology for NDA: 020850

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Suppliers and Packaging for NDA: 020850

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MICARDIS	telmisartan	TABLET;ORAL	020850	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0040	0597-0040-37	3 BLISTER PACK in 1 CARTON (0597-0040-37) / 10 TABLET in 1 BLISTER PACK
MICARDIS	telmisartan	TABLET;ORAL	020850	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0041	0597-0041-37	3 BLISTER PACK in 1 CARTON (0597-0041-37) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Nov 10, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Nov 10, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Apr 4, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 020850

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	⤷ Get Started Free	⤷ Get Started Free
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-003	Apr 4, 2000	⤷ Get Started Free	⤷ Get Started Free
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	⤷ Get Started Free	⤷ Get Started Free
Boehringer Ingelheim	MICARDIS	telmisartan	TABLET;ORAL	020850-002	Nov 10, 1998	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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