APPLICATION
ANDA208206
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-08
LATEST ACTION
2022-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RALOXIFENE HYDROCHLORIDEPrescription
RALOXIFENE HYDROCHLORIDE 60MG · TABLET · ORAL
Approval history
2022-10-11Labeling · Supplement 10 · standardAP
2019-08-23Labeling · Supplement 2 · standardAP
2016-04-08UNKNOWN · 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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