APPLICATION
ANDA219983
TYPE
ANDA
ORIGINAL APPROVAL
2026-01-20
LATEST ACTION
2026-01-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SACUBITRIL AND VALSARTANPrescription
SACUBITRIL 49MG, VALSARTAN 51MG · TABLET · ORAL
SACUBITRIL AND VALSARTANPrescription
SACUBITRIL 97MG, VALSARTAN 103MG · TABLET · ORAL
SACUBITRIL AND VALSARTANPrescription
SACUBITRIL 24MG, VALSARTAN 26MG · TABLET · ORAL
Approval history
2026-01-20UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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