APPLICATION
NDA021396
TYPE
NDA
ORIGINAL APPROVAL
2003-06-04
LATEST ACTION
2003-06-04
ROUTE
Oral
DOSAGE FORM
Tablet
MARKETING STATUS
Prescription
Products
PREMPRO/PREMPHASEPrescription
CONJUGATED ESTROGENS/MEDROXYPROGESTERONE ACETATE 0.45MG/1.5MG & 0.3MG/1.5MG · Tablet · Oral
Approval history
2003-06-04Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · standard — Label ↗AP
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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