Details for New Drug Application (NDA): 205536
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NDA 205536 describes VALSARTAN, which is a drug marketed by Novitium Pharma, 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, Ryan Labs, Sciegen Pharms Inc, Square Pharms, Torrent, Unichem, Watson Labs Inc, Zydus Lifesciences, Apotex Inc, Mylan Pharms Inc, and Watson Labs Teva, and is included in thirty-one NDAs. It is available from thirty-four 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. Nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 205536
| Tradename: | VALSARTAN |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | valsartan |
| Patents: | 0 |
Pharmacology for NDA: 205536
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 205536
Suppliers and Packaging for NDA: 205536
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALSARTAN | valsartan | TABLET;ORAL | 205536 | ANDA | American Health Packaging | 60687-612 | 60687-612-21 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-612-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-612-11) |
| VALSARTAN | valsartan | TABLET;ORAL | 205536 | ANDA | American Health Packaging | 60687-623 | 60687-623-01 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-623-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-623-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Mar 12, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Mar 12, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Mar 12, 2019 | TE: | AB | RLD: | No | ||||
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