Details for New Drug Application (NDA): 078946
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NDA 078946 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Watson Labs Teva, and Zydus Lifesciences, and is included in ten NDAs. It is available from eighteen suppliers. Additional details are available on the VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 078946
| Tradename: | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Applicant: | Lupin Ltd |
| Ingredient: | hydrochlorothiazide; valsartan |
| Patents: | 0 |
Pharmacology for NDA: 078946
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 078946
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALSARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; valsartan | TABLET;ORAL | 078946 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1784 | 53002-1784-3 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-1784-3) |
| VALSARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; valsartan | TABLET;ORAL | 078946 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1784 | 53002-1784-9 | 90 TABLET, FILM COATED in 1 BOTTLE (53002-1784-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;320MG | ||||
| Approval Date: | Mar 21, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;320MG | ||||
| Approval Date: | Mar 21, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;80MG | ||||
| Approval Date: | Mar 21, 2013 | TE: | AB | RLD: | No | ||||
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