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Drugs@FDA: FDA-Approved Drugs

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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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/20/1962 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012675s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/012675Orig1s015ltr.pdf
04/26/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
03/11/1992 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
06/02/1987 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
06/30/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
06/08/1979 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

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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