Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006460
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROTAMINE SULFATE PROTAMINE SULFATE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
08/13/1969 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
04/22/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1997 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/03/1996 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1994 SUPPL-27 Labeling

Label is not available on this site.

08/18/1993 SUPPL-26 Labeling

Label is not available on this site.

01/08/1991 SUPPL-24 Labeling

Label is not available on this site.

03/05/1990 SUPPL-23 Labeling

Label is not available on this site.

06/13/1989 SUPPL-22 Labeling

Label is not available on this site.

01/07/1988 SUPPL-21 Labeling

Label is not available on this site.

02/18/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/27/1986 SUPPL-18 Labeling

Label is not available on this site.

10/24/1985 SUPPL-17 Labeling

Label is not available on this site.

10/29/1985 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/25/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/21/1982 SUPPL-14 Labeling

Label is not available on this site.

06/17/1985 SUPPL-13 Labeling

Label is not available on this site.

01/21/1982 SUPPL-12 Labeling

Label is not available on this site.

06/16/1981 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/07/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1979 SUPPL-9 Labeling

Label is not available on this site.

07/21/1976 SUPPL-8 Labeling

Label is not available on this site.

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