Details for New Drug Application (NDA): 203020
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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 203020
Tradename: | IRBESARTAN |
Applicant: | Unichem |
Ingredient: | irbesartan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203020
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 203020
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IRBESARTAN | irbesartan | TABLET;ORAL | 203020 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-212 | 29300-212-05 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-212-05) |
IRBESARTAN | irbesartan | TABLET;ORAL | 203020 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-212 | 29300-212-13 | 30 TABLET in 1 BOTTLE, PLASTIC (29300-212-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 75MG | ||||
Approval Date: | Dec 7, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Dec 7, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
Approval Date: | Dec 7, 2015 | TE: | AB | RLD: | No |
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