Details for New Drug Application (NDA): 213611
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NDA 213611 describes SACUBITRIL AND VALSARTAN, which is a drug marketed by Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Dr Reddys, Hetero Labs Ltd Iii, Laurus, Lupin, Macleods Pharms Ltd, MSN, Novugen Pharma Sdn, Somerset Theraps Llc, Torrent, and Zydus Pharms, and is included in fourteen NDAs. It is available from twenty-five 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. Twenty-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. Twenty-six suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 213611
| Tradename: | SACUBITRIL AND VALSARTAN |
| Applicant: | Novugen Pharma Sdn |
| Ingredient: | sacubitril; valsartan |
| Patents: | 0 |
Pharmacology for NDA: 213611
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Suppliers and Packaging for NDA: 213611
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 213611 | ANDA | American Health Packaging | 60687-955 | 60687-955-57 | 60 BLISTER PACK in 1 CARTON (60687-955-57) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-955-11) |
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 213611 | ANDA | American Health Packaging | 60687-966 | 60687-966-57 | 60 BLISTER PACK in 1 CARTON (60687-966-57) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-966-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 24MG;26MG | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 49MG;51MG | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 97MG;103MG | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
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