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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206254
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROMIDEPSIN ROMIDEPSIN 10MG/VIAL POWDER;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
10/12/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206254Orig1s000ltr.pdf

ROMIDEPSIN

POWDER;INTRAVENOUS; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ISTODAX ROMIDEPSIN 10MG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 022393 CELGENE
ROMIDEPSIN ROMIDEPSIN 10MG/VIAL POWDER;INTRAVENOUS Prescription No AP 206254 FRESENIUS KABI USA
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