Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205696
Company: HONG KONG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTARABINE CYTARABINE 100MG/ML INJECTABLE;INJECTION 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
07/17/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CYTARABINE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTARABINE CYTARABINE 100MG/ML INJECTABLE;INJECTION Prescription No AP 076512 FRESENIUS KABI USA
CYTARABINE CYTARABINE 100MG/ML INJECTABLE;INJECTION Prescription No AP 205696 HONG KONG
CYTARABINE CYTARABINE 100MG/ML INJECTABLE;INJECTION Prescription No AP 075383 HOSPIRA
CYTARABINE CYTARABINE 100MG/ML INJECTABLE;INJECTION Prescription No AP 201784 MYLAN LABS LTD

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