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Last Updated: August 7, 2020

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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 two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. 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. Twelve 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:1
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 AUTHORIZED GENERIC West-Ward Pharmaceuticals Corp. 0054-0545 0054-0545-18 3 BLISTER PACK in 1 CARTON (0054-0545-18) > 10 TABLET in 1 BLISTER PACK
MICARDIS HCT hydrochlorothiazide; telmisartan TABLET;ORAL 021162 NDA AUTHORIZED GENERIC West-Ward Pharmaceuticals Corp. 0054-0546 0054-0546-18 3 BLISTER PACK in 1 CARTON (0054-0546-18) > 10 TABLET in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021162
Tradename Dosage Ingredient NDA Submissiondate
MICARDIS HCT TABLET;ORAL hydrochlorothiazide; telmisartan 021162 2008-12-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;40MG
Approval Date:Nov 17, 2000TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 10, 2020Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Nov 17, 2000TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 10, 2020Product Flag?Substance Flag?Delist Request?

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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
Mallinckrodt
Colorcon
Merck

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