Details for New Drug Application (NDA): 213676
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NDA 213676 describes SACUBITRIL AND VALSARTAN, which is a drug marketed by Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Laurus, Macleods Pharms Ltd, MSN, Torrent, and Zydus Pharms, and is included in nine NDAs. It is available from four suppliers. Additional details are available on the SACUBITRIL AND VALSARTAN profile page.
The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 213676
| Tradename: | SACUBITRIL AND VALSARTAN |
| Applicant: | Laurus |
| Ingredient: | sacubitril; valsartan |
| Patents: | 0 |
Pharmacology for NDA: 213676
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Suppliers and Packaging for NDA: 213676
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 213676 | ANDA | Laurus Labs Limited | 42385-930 | 42385-930-18 | 180 TABLET, FILM COATED in 1 BOTTLE (42385-930-18) |
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 213676 | ANDA | Laurus Labs Limited | 42385-930 | 42385-930-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-930-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 24MG;26MG | ||||
| Approval Date: | May 28, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 49MG;51MG | ||||
| Approval Date: | May 28, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 97MG;103MG | ||||
| Approval Date: | May 28, 2024 | TE: | AB | RLD: | No | ||||
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