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FDA ANDA · ANDA211701

SOLIFENACIN SUCCINATE

Sponsor: UNICHEM

APPLICATION
ANDA211701
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-27
LATEST ACTION
2021-01-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SOLIFENACIN SUCCINATEPrescription
SOLIFENACIN SUCCINATE 10MG · TABLET · ORAL
SOLIFENACIN SUCCINATEPrescription
SOLIFENACIN SUCCINATE 5MG · TABLET · ORAL

Approval history

2021-01-25Labeling · Supplement 4 · standardAP
2019-08-27UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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