Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075383
Company: HOSPIRA

Products on ANDA 075383

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075383

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
06/02/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 075383

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	075383	HOSPIRA
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205696	MEITHEAL
CYTARABINE	CYTARABINE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	201784	RISING