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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005264
Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN LOCK FLUSH HEPARIN SODIUM 100 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 2,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 2,500 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
PANHEPRIN HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
PANHEPRIN HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
PANHEPRIN HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
PANHEPRIN HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
PANHEPRIN HEPARIN SODIUM 40,000 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
05/04/1943 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
12/23/2011 SUPPL-93 Labeling-Package Insert

Label is not available on this site.
03/21/2000 SUPPL-73 Labeling

Label is not available on this site.
09/16/1998 SUPPL-70 Labeling

Label is not available on this site.
10/29/1992 SUPPL-65 Labeling

Label is not available on this site.
03/24/1992 SUPPL-63 Labeling

Label is not available on this site.
07/24/1991 SUPPL-60 Labeling

Label is not available on this site.
11/22/1988 SUPPL-58 Labeling

Label is not available on this site.
05/21/1985 SUPPL-50 Efficacy

Label is not available on this site.
10/04/1984 SUPPL-48 Labeling

Label is not available on this site.
10/26/1981 SUPPL-45 Labeling

Label is not available on this site.
04/22/1981 SUPPL-43 Labeling

Label is not available on this site.
05/15/1981 SUPPL-42 Efficacy

Label is not available on this site.
02/18/1981 SUPPL-40 Labeling

Label is not available on this site.
07/02/1980 SUPPL-39 Labeling

Label is not available on this site.
09/29/1980 SUPPL-37 Labeling

Label is not available on this site.
05/15/1978 SUPPL-31 Labeling

Label is not available on this site.
01/04/1978 SUPPL-29 Labeling

Label is not available on this site.
11/04/1977 SUPPL-27 Labeling

Label is not available on this site.
09/22/1976 SUPPL-20 Labeling

Label is not available on this site.
09/22/1976 SUPPL-19 Labeling

Label is not available on this site.
09/22/1976 SUPPL-18 Labeling

Label is not available on this site.
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