Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019387
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROFENAL SUPROFEN 1% SOLUTION/DROPS;OPHTHALMIC 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
12/23/1988 ORIG-1 Approval Type 3 - New Dosage Form 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
02/18/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/17/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/11/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1998 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/15/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/01/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/13/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/1992 SUPPL-2 Labeling

Label is not available on this site.

05/21/1992 SUPPL-1 Labeling

Label is not available on this site.

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