Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016851
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FML FLUOROMETHOLONE 0.1% 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
01/12/1972 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-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016851Orig1s063ltr.pdf
03/19/2003 SUPPL-59 Labeling

Label is not available on this site.

07/18/2002 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2002 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

07/24/2001 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

10/02/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/28/2001 SUPPL-51 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16851s51ltr.pdf
06/30/1998 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1998 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1996 SUPPL-48 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/05/1996 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1994 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1993 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1993 SUPPL-43 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/20/1992 SUPPL-42 Labeling

Label is not available on this site.

04/27/1989 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

10/12/1989 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

02/01/1989 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1992 SUPPL-38 Labeling

Label is not available on this site.

07/18/1986 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1984 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/14/1983 SUPPL-33 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/13/1982 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/28/1982 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/30/1980 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/27/1979 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1979 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1978 SUPPL-25 Labeling

Label is not available on this site.

09/12/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1978 SUPPL-23 Labeling

Label is not available on this site.

08/14/1978 SUPPL-22 Labeling

Label is not available on this site.

08/14/1978 SUPPL-21 Labeling

Label is not available on this site.

08/14/1978 SUPPL-19 Labeling

Label is not available on this site.

08/14/1978 SUPPL-17 Labeling

Label is not available on this site.

09/20/1978 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1978 SUPPL-14 Labeling

Label is not available on this site.

02/26/1975 SUPPL-13

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-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016851s063lbl.pdf
06/28/2001 SUPPL-51 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16851s51lbl.pdf

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