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New Drug Application (NDA): 018596
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTAL CROMOLYN SODIUM 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INHALATION Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/11/2004 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18596slr030_intal_lbl.pdf
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