Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017760
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FML FLUOROMETHOLONE 0.1% OINTMENT;OPHTHALMIC Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/04/1985 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
02/12/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017760s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017760Orig1s017ltr.pdf
09/12/2007 SUPPL-15 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017760s015ltr.pdf
04/12/2001 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/13/2001 SUPPL-9 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17760s9lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17760s9ltr.pdf
10/02/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/09/1999 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/07/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/11/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1992 SUPPL-2 Labeling

Label is not available on this site.

03/27/1987 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
02/12/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017760s017lbl.pdf
07/13/2001 SUPPL-9 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/17760s9lbl.pdf

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