Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007529
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINIDINE GLUCONATE QUINIDINE GLUCONATE 80MG/ML 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
07/12/1950 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2016 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

08/11/2014 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/09/1999 SUPPL-17 Labeling

Label is not available on this site.

06/15/1998 SUPPL-16 Labeling

Label is not available on this site.

03/29/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/20/1995 SUPPL-14 Labeling

Label is not available on this site.

03/07/1994 SUPPL-13 Labeling

Label is not available on this site.

12/06/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/17/1992 SUPPL-11 Labeling

Label is not available on this site.

06/12/1991 SUPPL-10 Efficacy-New Indication

Label is not available on this site.

07/10/1989 SUPPL-9 Labeling

Label is not available on this site.

02/10/1989 SUPPL-7 Labeling

Label is not available on this site.

02/10/1989 SUPPL-5 Labeling

Label is not available on this site.

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