Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017979
Company: ABRAXIS PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Discontinued None 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
12/21/1978 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2003 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/28/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/22/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/02/1995 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1993 SUPPL-21 Labeling

Label is not available on this site.

02/09/1989 SUPPL-18 Labeling

Label is not available on this site.

10/19/1988 SUPPL-16 Labeling

Label is not available on this site.

09/17/1986 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1985 SUPPL-14 Labeling

Label is not available on this site.

01/08/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/19/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/19/1983 SUPPL-11 Efficacy

Label is not available on this site.

01/12/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/23/1980 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/19/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1979 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/18/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1979 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1979 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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