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FDA ANDA · ANDA213605

SACUBITRIL AND VALSARTAN

Sponsor: CRYSTAL

APPLICATION
ANDA213605
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-28
LATEST ACTION
2024-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SACUBITRIL AND VALSARTANPrescription
SACUBITRIL 24MG, VALSARTAN 26MG · TABLET · ORAL
SACUBITRIL AND VALSARTANPrescription
SACUBITRIL 49MG, VALSARTAN 51MG · TABLET · ORAL
SACUBITRIL AND VALSARTANPrescription
SACUBITRIL 97MG, VALSARTAN 103MG · TABLET · ORAL

Approval history

2024-05-28UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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