Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014694
Company: ASPEN GLOBAL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEXADROL DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEXADROL DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
HEXADROL DEXAMETHASONE SODIUM PHOSPHATE EQ 20MG PHOSPHATE/ML INJECTABLE;INJECTION 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
12/04/1964 ORIG-1 Approval Type 2 - New Active Ingredient 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
07/16/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014694s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014694Orig1s030ltr.pdf
11/08/1995 SUPPL-28 Labeling

Label is not available on this site.

08/02/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/28/1994 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/24/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/28/1988 SUPPL-24 Labeling

Label is not available on this site.

06/02/1987 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1985 SUPPL-21 Labeling

Label is not available on this site.

01/23/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/27/1981 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/27/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/16/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014694s030lbl.pdf

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