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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017760
Company: ALLERGAN

Products on NDA 017760

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FML	FLUOROMETHOLONE	0.1%	OINTMENT;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017760

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.

Labels for NDA 017760

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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