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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021565
Company: ALLERGAN

Products on NDA 021565

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELESTAT	EPINASTINE HYDROCHLORIDE	0.05%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021565

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/16/2003	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21565ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-565_Elestat.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2016	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
06/17/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
12/20/2011	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021565s006ltr.pdf
08/15/2005	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021565s005ltr.pdf

Labels for NDA 021565

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2011	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021565s006lbl.pdf
08/15/2005	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021565s005lbl.pdf
10/16/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21565_elestat_lbl.pdf

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