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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016793
Company: TEVA PARENTERAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTARABINE CYTARABINE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
CYTARABINE CYTARABINE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
CYTARABINE CYTARABINE 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
CYTARABINE CYTARABINE 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/17/1969 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2000 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.
10/15/1998 SUPPL-59 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/016793s059ltr.pdf
01/24/1996 SUPPL-58 Labeling

Label is not available on this site.
11/01/1995 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.
06/14/1995 SUPPL-56 Labeling

Label is not available on this site.
09/27/1994 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.
01/08/1990 SUPPL-52 Labeling

Label is not available on this site.
12/21/1987 SUPPL-51 Labeling

Label is not available on this site.
02/24/1987 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.
04/17/1987 SUPPL-49 Labeling

Label is not available on this site.
12/21/1987 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/28/1986 SUPPL-46 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
10/21/1983 SUPPL-41 Labeling

Label is not available on this site.
01/31/1986 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.
05/11/1983 SUPPL-38 Labeling

Label is not available on this site.
12/30/1982 SUPPL-37 Labeling

Label is not available on this site.
03/31/1981 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/23/1979 SUPPL-33 Labeling

Label is not available on this site.
10/29/1979 SUPPL-32 Labeling

Label is not available on this site.
03/10/1976 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
10/23/1975 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.
04/24/1974 SUPPL-25 Unspecified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/15/1998 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/016793s059lbl.pdf
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