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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017007
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN LOCK FLUSH HEPARIN SODIUM 10 UNITS/ML INJECTABLE; INJECTION Discontinued None No No
HEPARIN LOCK FLUSH HEPARIN SODIUM 100 UNITS/ML INJECTABLE; INJECTION Discontinued None No No
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEPARIN SODIUM HEPARIN SODIUM 7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEPARIN SODIUM HEPARIN SODIUM 15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEPARIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEPARIN SODIUM HEPARIN SODIUM 2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
05/28/1974 ORIG-1 Approval Type 3 - New Dosage Form 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
10/24/2024 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017007s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017007Orig1s040ltr.pdf
03/27/2018 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017007s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017007Orig1s039ltredt.pdf
09/06/2000 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/017007Orig2s038Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/017007Orig2s038Ltr.pdf
03/05/1997 SUPPL-36 Labeling

Label is not available on this site.
05/20/1996 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/20/1993 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/14/1993 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/20/1990 SUPPL-31 Labeling

Label is not available on this site.
07/13/1989 SUPPL-29 Labeling

Label is not available on this site.
06/29/1989 SUPPL-28 Labeling

Label is not available on this site.
02/28/1991 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.
07/29/1987 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/14/1987 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/05/1987 SUPPL-22 Labeling

Label is not available on this site.
10/19/1983 SUPPL-19 Labeling

Label is not available on this site.
08/29/1983 SUPPL-18 Labeling

Label is not available on this site.
05/25/1983 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/30/1982 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
04/07/1986 SUPPL-15 Labeling

Label is not available on this site.
05/14/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
07/02/1980 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
07/02/1980 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
10/04/1978 SUPPL-11 Labeling

Label is not available on this site.
07/03/1978 SUPPL-10 Labeling

Label is not available on this site.
07/03/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
02/02/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/02/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
12/29/1976 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/17/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
12/12/1975 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
03/28/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/24/2024 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017007s040lbl.pdf
03/27/2018 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017007s039lbl.pdf
09/06/2000 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/017007Orig2s038Lbl.pdf
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