Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017063
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISMOTIC ISOSORBIDE 100GM/220ML SOLUTION;ORAL 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
01/30/1974 ORIG-1 Approval Type 2 - New Active Ingredient 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
04/07/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/05/1998 SUPPL-11 Labeling

Label is not available on this site.

07/13/1993 SUPPL-9 Labeling

Label is not available on this site.

03/04/1988 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1981 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1980 SUPPL-6 Labeling

Label is not available on this site.

01/09/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1978 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/25/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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