Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019216
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FML FORTE FLUOROMETHOLONE 0.25% SUSPENSION/DROPS;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
04/23/1986 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-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019216s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019216Orig1s025ltr.pdf
01/10/2006 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019216s021s022ltr.pdf
01/10/2006 SUPPL-21 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019216s021s022ltr.pdf
09/04/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/28/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/14/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/1997 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/08/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1992 SUPPL-7 Labeling

Label is not available on this site.

02/27/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/17/1989 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1990 SUPPL-3 Labeling

Label is not available on this site.

08/28/1986 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1986 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-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019216s025lbl.pdf
01/10/2006 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf
01/10/2006 SUPPL-21 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019216s021s022lbl.pdf

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