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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 014694
Company: ASPEN GLOBAL INC

Safety Labeling Change Order Letter

Products on NDA 014694

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DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No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DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 014694

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.

Labels for NDA 014694

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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