Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071868
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTARABINE CYTARABINE 20MG/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
06/04/1990 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2019 SUPPL-31 Labeling-Container/Carton Labels

Label is not available on this site.

01/15/2019 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

01/15/2019 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

05/14/2001 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/08/2000 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/18/2000 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/12/2000 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/28/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/02/1997 SUPPL-9 Labeling

Label is not available on this site.

04/16/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/28/1995 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/23/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/23/1994 SUPPL-5 Labeling

Label is not available on this site.

03/25/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/28/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/15/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/31/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CYTARABINE

INJECTABLE;INJECTION; 20MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTARABINE CYTARABINE 20MG/ML INJECTABLE;INJECTION Prescription No AP 206190 HONG KONG
CYTARABINE CYTARABINE 20MG/ML INJECTABLE;INJECTION Prescription No AP 071868 HOSPIRA
CYTARABINE CYTARABINE 20MG/ML INJECTABLE;INJECTION Prescription No AP 072168 HOSPIRA
CYTARABINE CYTARABINE 20MG/ML INJECTABLE;INJECTION Prescription No AP 072945 HOSPIRA
CYTARABINE CYTARABINE 20MG/ML INJECTABLE;INJECTION Prescription No AP 200914 MYLAN LABS LTD
CYTARABINE CYTARABINE 20MG/ML INJECTABLE;INJECTION Prescription No AP 200915 MYLAN LABS LTD
CYTARABINE CYTARABINE 20MG/ML INJECTABLE;INJECTION Prescription No AP 200916 MYLAN LABS LTD

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