Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012674
Company: ASPEN GLOBAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEXADROL DEXAMETHASONE 0.5MG/5ML ELIXIR;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
12/21/1960 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
06/02/1987 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1989 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1984 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

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