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FDA NDA · NDA210326

FULVESTRANT

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA210326
TYPE
NDA
ORIGINAL APPROVAL
2019-05-20
LATEST ACTION
2021-05-12
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FULVESTRANTPrescription
FULVESTRANT 250MG/5ML (50MG/ML) · SOLUTION · INTRAMUSCULAR

Approval history

2021-05-12Efficacy · Supplement 1 · standard — Letter ↗AP
2021-05-12Labeling · Supplement 2 · standard — Letter ↗AP
2019-05-20Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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