Details for New Drug Application (NDA): 206511
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The generic ingredient in TELMISARTAN 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 206511
Tradename: | TELMISARTAN |
Applicant: | Aurobindo Pharma |
Ingredient: | telmisartan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206511
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 206511
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TELMISARTAN | telmisartan | TABLET;ORAL | 206511 | ANDA | Aurobindo Pharma Limited | 65862-867 | 65862-867-03 | 3 BLISTER PACK in 1 CARTON (65862-867-03) / 10 TABLET in 1 BLISTER PACK (65862-867-10) |
TELMISARTAN | telmisartan | TABLET;ORAL | 206511 | ANDA | Aurobindo Pharma Limited | 65862-867 | 65862-867-30 | 30 TABLET in 1 BOTTLE (65862-867-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Sep 3, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Sep 3, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Sep 3, 2015 | TE: | AB | RLD: | No |
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