APPLICATION
ANDA210965
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-06
LATEST ACTION
2020-06-04
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROGESTERONEPrescription
PROGESTERONE 50MG/ML · INJECTABLE · INJECTION
Approval history
2020-06-04Labeling · Supplement 1 · standardAP
2018-12-06UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.