Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075383
Company: HOSPIRA
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
11/22/1999 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75383ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075383.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2019 SUPPL-17 Labeling-Container/Carton Labels

Label is not available on this site.

10/03/2018 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/14/2001 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/28/2000 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/17/2000 SUPPL-1 Manufacturing (CMC)-Control

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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