Details for New Drug Application (NDA): 020850
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The generic ingredient in MICARDIS is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Ten 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 |
Formulation / Manufacturing: | see details |
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. | 0597-0039 | 0597-0039-37 | 3 BLISTER PACK in 1 CARTON (0597-0039-37) / 10 TABLET in 1 BLISTER PACK |
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 |
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: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Nov 10, 1998 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Apr 4, 2000 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020850
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-003 | Apr 4, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MICARDIS | telmisartan | TABLET;ORAL | 020850-001 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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