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New Drug Application (NDA): 012675
Company: ASPEN GLOBAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEXADROL DEXAMETHASONE 0.5MG TABLET;ORAL Discontinued None No No
HEXADROL DEXAMETHASONE 0.75MG TABLET;ORAL Discontinued None No No
HEXADROL DEXAMETHASONE 1.5MG TABLET;ORAL Discontinued None No No
HEXADROL DEXAMETHASONE 4MG TABLET;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/05/2024 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012675s015lbl.pdf
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