Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017979
Company: ABRAXIS PHARM

Products on NDA 017979

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017979

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.