Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019525
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FML-S FLUOROMETHOLONE; SULFACETAMIDE SODIUM 0.1%;10% SUSPENSION/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
09/29/1989 ORIG-1 Approval Type 4 - New Combination 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
04/12/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/10/2005 SUPPL-10 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19525S010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19525S010ltr.pdf
04/12/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/09/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/03/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/09/1990 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/10/2005 SUPPL-10 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19525S010lbl.pdf

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