Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021009
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOCRIL NEDOCROMIL SODIUM 2% SOLUTION/DROPS;OPHTHALMIC Prescription AT 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
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.

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

ALOCRIL

SOLUTION/DROPS;OPHTHALMIC; 2%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOCRIL NEDOCROMIL SODIUM 2% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 021009 ALLERGAN
NEDOCROMIL SODIUM NEDOCROMIL SODIUM 2% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 090638 AKORN

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