Details for New Drug Application (NDA): 204687
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NDA 204687 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, Sciegen Pharms, Watson Labs Teva, and Zydus Lifesciences, and is included in eleven NDAs. It is available from fifteen 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 204687
| Tradename: | VALSARTAN AND HYDROCHLOROTHIAZIDE |
| Applicant: | Sciegen Pharms |
| Ingredient: | hydrochlorothiazide; valsartan |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;80MG | ||||
| Approval Date: | Apr 23, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;160MG | ||||
| Approval Date: | Apr 23, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;320MG | ||||
| Approval Date: | Apr 23, 2026 | TE: | AB | RLD: | No | ||||
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