Details for New Drug Application (NDA): 203081
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The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 203081
Tradename: | IRBESARTAN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | irbesartan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203081
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 203081
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IRBESARTAN | irbesartan | TABLET;ORAL | 203081 | ANDA | Aurobindo Pharma Limited | 65862-637 | 65862-637-05 | 500 TABLET in 1 BOTTLE (65862-637-05) |
IRBESARTAN | irbesartan | TABLET;ORAL | 203081 | ANDA | Aurobindo Pharma Limited | 65862-637 | 65862-637-30 | 30 TABLET in 1 BOTTLE (65862-637-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Sep 27, 2012 | TE: | AB | RLD: | No |
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