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Abbreviated New Drug Application (ANDA): 208231
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/31/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208231Orig1s000ltr.pdf

ARSENIC TRIOXIDE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 210739 AMNEAL
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 210802 AMRING PHARMS
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 208231 FRESENIUS KABI USA
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 215059 GLAND PHARMA LTD
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 209315 INGENUS PHARMS LLC
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 209780 NEXUS PHARMS
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 209873 STI PHARMA LLC
ARSENIC TRIOXIDE ARSENIC TRIOXIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 206228 ZYDUS PHARMS
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