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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019525
Company: ALLERGAN

Products on NDA 019525

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019525

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.

Labels for NDA 019525

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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