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Drugs@FDA: FDA-Approved Drugs

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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ALOCRIL NEDOCROMIL SODIUM 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
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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