Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080020
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOPTO CETAMIDE SULFACETAMIDE SODIUM 15% 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
05/05/1971 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
12/23/2002 SUPPL-31 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/07/2000 SUPPL-30 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-29 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/23/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-26 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/27/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/31/1996 SUPPL-24 Labeling

Label is not available on this site.

10/05/1995 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/21/1995 SUPPL-19 Labeling

Label is not available on this site.

08/03/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/03/1993 SUPPL-17 Labeling

Label is not available on this site.

06/04/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/11/1991 SUPPL-15 Labeling

Label is not available on this site.

06/04/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

09/15/1989 SUPPL-13 Labeling

Label is not available on this site.

04/26/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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