U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210044
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;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)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210044Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/21/2024 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
03/21/2024 SUPPL-13 Labeling-Package Insert

Label is not available on this site.
03/21/2024 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
03/21/2024 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
03/21/2024 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert

Label is not available on this site.
03/21/2024 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

FULVESTRANT

SOLUTION;INTRAMUSCULAR; 250MG/5ML (50MG/ML)
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FASLODEX FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription Yes AO 021344 ASTRAZENECA
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 211689 ACCORD HLTHCARE
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 215077 ALEMBIC
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 210044 AMNEAL
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 211422 CHIA TAI TIANQING
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 209246 DR REDDYS
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 210326 FRESENIUS KABI USA
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 207754 GLENMARK PHARMS
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 209714 HBT LABS INC
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 214682 JIANGSU HANSOH PHARM
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 205871 SAGENT PHARMS INC
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 205935 SANDOZ
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 213553 XIROMED
FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION;INTRAMUSCULAR Prescription No AO 215234 ZYDUS PHARMS
Back to Top