Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 004570
Company: PHARMACIA AND UPJOHN
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/05/1942 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
04/03/2000 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

09/15/1999 SUPPL-55 Labeling

Label is not available on this site.

03/04/1996 SUPPL-54 Labeling

Label is not available on this site.

01/31/1996 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

07/09/1991 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1988 SUPPL-51 Labeling

Label is not available on this site.

08/12/1988 SUPPL-50 Labeling

Label is not available on this site.

01/29/1990 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1987 SUPPL-48 Labeling

Label is not available on this site.

01/21/1987 SUPPL-47 Labeling

Label is not available on this site.

01/29/1988 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1983 SUPPL-45 Labeling

Label is not available on this site.

01/21/1983 SUPPL-44 Labeling

Label is not available on this site.

10/24/1986 SUPPL-43 Labeling

Label is not available on this site.

08/19/1981 SUPPL-42 Labeling

Label is not available on this site.

06/02/1981 SUPPL-41 Labeling

Label is not available on this site.

02/04/1981 SUPPL-40 Labeling

Label is not available on this site.

01/14/1981 SUPPL-39 Labeling

Label is not available on this site.

12/03/1980 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1980 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1980 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1981 SUPPL-35 Labeling

Label is not available on this site.

02/05/1980 SUPPL-34 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/02/1981 SUPPL-33 Labeling

Label is not available on this site.

02/05/1980 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1980 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/04/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1978 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1977 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/24/1976 SUPPL-22 Labeling

Label is not available on this site.

02/24/1976 SUPPL-21 Labeling

Label is not available on this site.

07/09/1976 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/14/1975 SUPPL-19 Labeling

Label is not available on this site.

08/14/1975 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

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