Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071868
Company: HOSPIRA

Products on ANDA 071868

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071868

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
06/02/2020	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/071868s032lbl.pdf
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.

Labels for ANDA 071868

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2020	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/071868s032lbl.pdf

Therapeutic Equivalents for ANDA 071868

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	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	208485	MEITHEAL
CYTARABINE	CYTARABINE	20MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	200915	RISING