Drugs@FDA: FDA-Approved Drugs
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HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
HEPARIN SODIUM | HEPARIN SODIUM | 7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
HEPARIN SODIUM | HEPARIN SODIUM | 15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
HEPARIN SODIUM | HEPARIN SODIUM | 20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
HEPARIN SODIUM | HEPARIN SODIUM | 2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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SODIUM | HEPARIN SODIUM | 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
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 |