Details for New Drug Application (NDA): 218991
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NDA 218991 describes VALSARTAN, which is a drug marketed by Novitium Pharma, Rubicon, Acme Labs, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Sciegen Pharms Inc, Somerset Theraps Llc, Torrent, Unichem, Watson Labs Inc, Zydus Lifesciences, Apotex Inc, Mylan Pharms Inc, and Watson Labs Teva, and is included in thirty-two NDAs. It is available from thirty-two suppliers. Additional details are available on the VALSARTAN profile page.
The generic ingredient in VALSARTAN 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 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 218991
| Tradename: | VALSARTAN |
| Applicant: | Zydus Lifesciences |
| Ingredient: | valsartan |
| Patents: | 0 |
Pharmacology for NDA: 218991
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 218991
Suppliers and Packaging for NDA: 218991
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALSARTAN | valsartan | TABLET;ORAL | 218991 | ANDA | Zydus Lifesciences Limited | 70771-1882 | 70771-1882-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1882-3) |
| VALSARTAN | valsartan | TABLET;ORAL | 218991 | ANDA | Zydus Lifesciences Limited | 70771-1883 | 70771-1883-9 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1883-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | AB | RLD: | No | ||||
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