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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 000552
Company: ORGANON USA INC

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 5,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN LOCK FLUSH HEPARIN SODIUM 100 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM HEPARIN SODIUM 20,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM HEPARIN SODIUM 40,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM HEPARIN SODIUM 10,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 1,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
LIQUAEMIN SODIUM PRESERVATIVE FREE HEPARIN SODIUM 10,000 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
02/09/1939 ORIG-1 Approval UNKNOWN

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
08/05/1988 SUPPL-23 Labeling

Label is not available on this site.
12/09/1987 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
01/06/1987 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/28/1986 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
04/11/1986 SUPPL-18 Efficacy-New Dosing Regimen

Label is not available on this site.
05/13/1985 SUPPL-17 Labeling

Label is not available on this site.
11/28/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
11/28/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
03/24/1981 SUPPL-13 Labeling

Label is not available on this site.
01/25/1978 SUPPL-12 Labeling

Label is not available on this site.
06/08/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
05/15/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
07/28/1975 SUPPL-8 Unspecified

Label is not available on this site.
07/28/1975 SUPPL-7 Unspecified

Label is not available on this site.
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