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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218047
Company: GLAND

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ERIBULIN MESYLATE ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
04/05/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218047Orig1s000ltr.pdf

ERIBULIN MESYLATE

SOLUTION;INTRAVENOUS; 1MG/2ML (0.5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ERIBULIN MESYLATE ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 217250 BAXTER HLTHCARE CORP
ERIBULIN MESYLATE ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218743 CHIA TAI TIANQING
ERIBULIN MESYLATE ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218047 GLAND
ERIBULIN MESYLATE ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 218281 JIANGXI QINGFENG
ERIBULIN MESYLATE ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 214850 LONG GROVE PHARMS
HALAVEN ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 201532 EISAI INC
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