Details for New Drug Application (NDA): 205357
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NDA 205357 describes VALSARTAN, which is a drug marketed by Novitium Pharma, Rubicon Research, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Bostal Drug, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Laurus, Lupin, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Renata, Sciegen Pharms, Square Pharms Plc, Torrent, Unichem, Watson Labs Inc, Zydus Lifesciences, Apotex Inc, Lupin Ltd, Mylan Pharms Inc, and Watson Labs Teva, and is included in thirty-five NDAs. It is available from thirty-three suppliers. Additional details are available on the VALSARTAN profile page.
The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 205357
| Tradename: | VALSARTAN |
| Applicant: | Bostal Drug |
| Ingredient: | valsartan |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 205357
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Aug 11, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Aug 11, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Aug 11, 2026 | TE: | AB | RLD: | No | ||||
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