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Last Updated: March 29, 2024

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. Nine 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 ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased 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:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Nov 17, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Nov 17, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;80MG
Approval Date:Apr 19, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021162

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