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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021009
Company: ALLERGAN

Products on NDA 021009

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOCRIL	NEDOCROMIL SODIUM	2%	SOLUTION/DROPS;OPHTHALMIC	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021009

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/1999	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021009_Alocril.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2016	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/07/2008	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021009s010ltr.pdf
10/18/2004	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf
10/18/2004	SUPPL-8	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21009s008,009ltr.pdf
08/21/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf
08/21/2007	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021009s003, 021009s004ltr.pdf
03/08/2002	SUPPL-2	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21009s2ltr.pdf
07/18/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 021009

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/2008	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021009s010lbl.pdf
08/21/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf
08/21/2007	SUPPL-3	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021009s003s004lbl.pdf
12/08/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21009lbl.pdf

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