Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210044
Company: AMNEAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FULVESTRANT FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR Prescription AO No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/04/2019 ORIG-1 Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210044Orig1s000ltr.pdf

FULVESTRANT

INJECTABLE;INTRAMUSCULAR; 50MG/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FASLODEX FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR Prescription Yes AO 021344 ASTRAZENECA
FULVESTRANT FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR Prescription No AO 210044 AMNEAL
FULVESTRANT FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR Prescription No AO 207754 GLENMARK PHARMS INC
FULVESTRANT FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR Prescription No AO 208811 MYLAN INSTITUTIONAL
FULVESTRANT FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR Prescription No AO 205871 SAGENT PHARMS INC
FULVESTRANT FULVESTRANT 50MG/ML INJECTABLE;INTRAMUSCULAR Prescription No AO 205935 SANDOZ INC

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