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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 213605


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NDA 213605 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-three 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-four suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 213605
Tradename:SACUBITRIL AND VALSARTAN
Applicant:Crystal
Ingredient:sacubitril; valsartan
Patents:0
Pharmacology for NDA: 213605
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Neprilysin Inhibitors
Suppliers and Packaging for NDA: 213605
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213605 ANDA Amneal Pharmaceuticals NY LLC 69238-2731 69238-2731-1 60 TABLET, FILM COATED in 1 BOTTLE (69238-2731-1)
SACUBITRIL AND VALSARTAN sacubitril; valsartan TABLET;ORAL 213605 ANDA Amneal Pharmaceuticals NY LLC 69238-2731 69238-2731-2 180 TABLET, FILM COATED in 1 BOTTLE (69238-2731-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength24MG;26MG
Approval Date:May 28, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength49MG;51MG
Approval Date:May 28, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength97MG;103MG
Approval Date:May 28, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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