APPLICATION
ANDA076553
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-28
LATEST ACTION
2021-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MEDROXYPROGESTERONE ACETATEPrescription
MEDROXYPROGESTERONE ACETATE 150MG/ML · INJECTABLE · INJECTION
Approval history
2021-12-08Labeling · Supplement 30 · standardAP
2021-12-08Labeling · Supplement 22 · standardAP
2021-12-08Labeling · Supplement 31 · standardAP
2021-12-08Labeling · Supplement 23 · standardAP
2011-11-30Labeling · Supplement 15AP
2005-03-04Labeling · Supplement 2AP
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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