Details for New Drug Application (NDA): 219946
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NDA 219946 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, MSN, Novugen Pharma Sdn, Somerset Theraps Llc, Torrent, Umedica, and Zydus Pharms, and is included in fifteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the SACUBITRIL AND VALSARTAN profile page.
The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There is one drug master file entry for this compound. Twenty-eight 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 is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 219946
| Tradename: | SACUBITRIL AND VALSARTAN |
| Applicant: | Umedica |
| Ingredient: | sacubitril; valsartan |
| Patents: | 0 |
Pharmacology for NDA: 219946
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Suppliers and Packaging for NDA: 219946
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 219946 | ANDA | Umedica Laboratories USA Inc. | 60290-085 | 60290-085-01 | 60 TABLET, FILM COATED in 1 BOTTLE (60290-085-01) |
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 219946 | ANDA | Umedica Laboratories USA Inc. | 60290-085 | 60290-085-02 | 180 TABLET, FILM COATED in 1 BOTTLE (60290-085-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 24MG;26MG | ||||
| Approval Date: | Aug 4, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 49MG;51MG | ||||
| Approval Date: | Aug 4, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 97MG;103MG | ||||
| Approval Date: | Aug 4, 2026 | TE: | AB | RLD: | No | ||||
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