Details for New Drug Application (NDA): 090351
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NDA 090351 describes IRBESARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sandoz, Teva, Unichem, and Watson Labs Inc, and is included in fifteen NDAs. It is available from twelve suppliers. Additional details are available on the IRBESARTAN AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 090351
| Tradename: | IRBESARTAN AND HYDROCHLOROTHIAZIDE |
| Applicant: | Hikma |
| Ingredient: | hydrochlorothiazide; irbesartan |
| Patents: | 0 |
Pharmacology for NDA: 090351
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 090351
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 090351 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0254 | 0054-0254-13 | 30 TABLET in 1 BOTTLE (0054-0254-13) |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 090351 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0254 | 0054-0254-22 | 90 TABLET in 1 BOTTLE (0054-0254-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;150MG | ||||
| Approval Date: | Oct 15, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;300MG | ||||
| Approval Date: | Oct 15, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;300MG | ||||
| Approval Date: | Jun 8, 2017 | TE: | AB | RLD: | No | ||||
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