APPLICATION
ANDA205935
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-14
LATEST ACTION
2021-03-19
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FULVESTRANTPrescription
FULVESTRANT 250MG/5ML (50MG/ML) · SOLUTION · INTRAMUSCULAR
Approval history
2021-03-19Labeling · Supplement 5 · standardAP
2021-03-19Labeling · Supplement 6 · standardAP
2021-03-19Labeling · Supplement 4 · standardAP
2021-03-19Labeling · Supplement 2 · standardAP
2019-05-14UNKNOWN · 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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