Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017037
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription AP Yes Yes
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription AP Yes Yes
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription AP Yes Yes
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/0.5ML 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
03/22/1972 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
05/18/2019 SUPPL-183 Manufacturing (CMC)-Formulation Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017037Orig1s183lbl.pdf
05/09/2017 SUPPL-178 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017037s178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017037Orig1s178ltr.pdf
10/30/2015 SUPPL-176 Manufacturing (CMC)

Label is not available on this site.

12/23/2015 SUPPL-175 Manufacturing (CMC)

Label is not available on this site.

12/02/2015 SUPPL-174 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-173 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-172 Manufacturing (CMC)

Label is not available on this site.

01/09/2014 SUPPL-171 Manufacturing (CMC)

Label is not available on this site.

08/27/2013 SUPPL-170 Manufacturing (CMC)

Label is not available on this site.

12/23/2011 SUPPL-169 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s169ltr.pdf
02/23/2011 SUPPL-168 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017037s168ltr.pdf
10/01/2009 SUPPL-165 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s165ltr.pdf
02/17/2009 SUPPL-162 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017037s162ltr.pdf
12/14/2007 SUPPL-161 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017037s161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017037s161ltr.pdf
10/04/2006 SUPPL-158 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017037s158LTR.pdf
09/02/2005 SUPPL-156 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf
09/02/2005 SUPPL-155 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf
09/02/2005 SUPPL-154 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017037s154,055,156ltr.pdf
11/22/2002 SUPPL-151 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/25/2002 SUPPL-150 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/21/2002 SUPPL-149 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/22/2002 SUPPL-148 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/15/2002 SUPPL-147 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/05/2002 SUPPL-146 Labeling

Label is not available on this site.

08/31/2001 SUPPL-145 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/2000 SUPPL-144 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/31/2000 SUPPL-143 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/2000 SUPPL-142 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/2000 SUPPL-141 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/2000 SUPPL-140 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2000 SUPPL-139 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1999 SUPPL-138 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1999 SUPPL-136 Labeling

Label is not available on this site.

02/20/1998 SUPPL-134 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1998 SUPPL-133 Labeling

Label is not available on this site.

04/24/1997 SUPPL-132 Manufacturing (CMC)

Label is not available on this site.

03/05/1996 SUPPL-131 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1993 SUPPL-130 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1991 SUPPL-128 Labeling

Label is not available on this site.

09/27/1989 SUPPL-127 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/20/1989 SUPPL-126 Labeling

Label is not available on this site.

06/20/1989 SUPPL-125 Labeling

Label is not available on this site.

06/28/1989 SUPPL-124 Labeling

Label is not available on this site.

10/14/1987 SUPPL-123 Labeling

Label is not available on this site.

09/16/1987 SUPPL-122 Labeling

Label is not available on this site.

07/02/1987 SUPPL-121 Labeling

Label is not available on this site.

07/02/1987 SUPPL-120 Labeling

Label is not available on this site.

04/24/1987 SUPPL-119 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1987 SUPPL-118 Manufacturing (CMC)

Label is not available on this site.

04/29/1987 SUPPL-117 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/23/1986 SUPPL-116 Manufacturing (CMC)

Label is not available on this site.

04/29/1987 SUPPL-115 Labeling

Label is not available on this site.

01/30/1986 SUPPL-114 Labeling

Label is not available on this site.

10/10/1985 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.

04/07/1986 SUPPL-112 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/29/1985 SUPPL-111 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/29/1985 SUPPL-110 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1985 SUPPL-109 Labeling

Label is not available on this site.

01/21/1986 SUPPL-108 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/11/1984 SUPPL-107 Labeling

Label is not available on this site.

10/11/1984 SUPPL-105 Labeling

Label is not available on this site.

08/02/1984 SUPPL-104 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/21/1983 SUPPL-102 Labeling

Label is not available on this site.

09/05/1983 SUPPL-101 Labeling

Label is not available on this site.

06/10/1983 SUPPL-100 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1983 SUPPL-99 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1982 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

08/18/1982 SUPPL-97 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1982 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

11/20/1981 SUPPL-95 Labeling

Label is not available on this site.

05/22/1981 SUPPL-94 Labeling

Label is not available on this site.

01/21/1980 SUPPL-93 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1979 SUPPL-92 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/06/1979 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1979 SUPPL-90 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1979 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1979 SUPPL-88 Labeling

Label is not available on this site.

10/04/1978 SUPPL-87 Labeling

Label is not available on this site.

08/04/1978 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1978 SUPPL-85 Labeling

Label is not available on this site.

08/04/1978 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

07/31/1978 SUPPL-83 Manufacturing (CMC)

Label is not available on this site.

07/31/1978 SUPPL-82 Labeling

Label is not available on this site.

12/14/1977 SUPPL-81 Labeling

Label is not available on this site.

12/14/1977 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

12/14/1977 SUPPL-79 Labeling

Label is not available on this site.

04/27/1978 SUPPL-78 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1978 SUPPL-77 Labeling

Label is not available on this site.

12/14/1977 SUPPL-75 Labeling

Label is not available on this site.

12/14/1977 SUPPL-74 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/03/1978 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

08/02/1977 SUPPL-72 Labeling

Label is not available on this site.

05/26/1977 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1977 SUPPL-70 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/26/1977 SUPPL-69 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/17/1977 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1976 SUPPL-66 Labeling

Label is not available on this site.

10/19/1976 SUPPL-65 Labeling

Label is not available on this site.

09/08/1976 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1976 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1976 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1976 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1976 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

06/25/1976 SUPPL-54 Labeling

Label is not available on this site.

09/03/1976 SUPPL-52 Labeling

Label is not available on this site.

09/03/1976 SUPPL-51 Labeling

Label is not available on this site.

01/09/1976 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1975 SUPPL-47 Labeling

Label is not available on this site.

09/04/1975 SUPPL-46 Labeling

Label is not available on this site.

09/04/1975 SUPPL-45 Labeling

Label is not available on this site.

09/04/1975 SUPPL-44 Labeling

Label is not available on this site.

09/04/1975 SUPPL-43 Labeling

Label is not available on this site.

09/04/1975 SUPPL-42 Labeling

Label is not available on this site.

04/23/1975 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1975 SUPPL-38 Labeling

Label is not available on this site.

03/05/1984 SUPPL-13 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/18/2019 SUPPL-183 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017037Orig1s183lbl.pdf
05/09/2017 SUPPL-178 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017037s178lbl.pdf
12/23/2011 SUPPL-169 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s169.pdf
02/23/2011 SUPPL-168 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017037s168lbl.pdf
10/01/2009 SUPPL-165 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017037s165lbl.pdf
12/14/2007 SUPPL-161 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017037s161lbl.pdf
10/04/2006 SUPPL-158 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017037s158lbl.pdf
09/02/2005 SUPPL-156 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf
09/02/2005 SUPPL-155 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf
09/02/2005 SUPPL-154 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017037s154,055,156lbl.pdf

HEPARIN SODIUM

INJECTABLE;INJECTION; 1,000 UNITS/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017037 HIKMA
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090571 HOSPIRA INC
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203851 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211005 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090808 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091682 SANDOZ
HEPARIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202957 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090810 SAGENT PHARMS
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202732 SHENZHEN TECHDOW

INJECTABLE;INJECTION; 5,000 UNITS/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091659 CASI PHARMS INC
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017651 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 206552 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 205323 GLAND PHARMA LTD
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017037 HIKMA
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090571 HOSPIRA INC
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203851 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090808 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 091682 SANDOZ
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202733 SHENZHEN TECHDOW
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 202957 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA

INJECTABLE;INJECTION; 10,000 UNITS/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017037 HIKMA
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090571 HOSPIRA INC
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203851 MYLAN LABS LTD
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 211007 NANJING KING-FRIEND
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 090808 SAGENT PHARMS
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 201002 SANDOZ
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription No AP 203198 SHENZHEN TECHDOW
HEPARIN SODIUM IN PLASTIC CONTAINER HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Prescription Yes AP 017029 FRESENIUS KABI USA

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