APPLICATION
ANDA206384
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-12
LATEST ACTION
2019-08-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RALOXIFENE HYDROCHLORIDEPrescription
RALOXIFENE HYDROCHLORIDE 60MG · TABLET · ORAL
Approval history
2019-08-23Labeling · Supplement 4 · standardAP
2016-10-12UNKNOWN · 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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