Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005521
Company: LILLY
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 10,000 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
HEPARIN SODIUM HEPARIN SODIUM 20,000 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
05/19/1944 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/23/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/05/1998 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/1996 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/29/1989 SUPPL-21 Labeling

Label is not available on this site.

10/27/1989 SUPPL-20 Labeling

Label is not available on this site.

04/27/1999 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/01/1989 SUPPL-18 Labeling

Label is not available on this site.

06/01/1989 SUPPL-17 Labeling

Label is not available on this site.

05/13/1985 SUPPL-16 Labeling

Label is not available on this site.

06/16/1981 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/19/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1979 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/1980 SUPPL-12 Labeling

Label is not available on this site.

07/08/1982 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1976 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

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