Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019790
Company: AUXILIUM PHARMS LLC

Products on NDA 019790

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILATRATE-SR	ISOSORBIDE DINITRATE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019790

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/1988	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
10/24/2014	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019790Orig1s011ltr.pdf
01/30/2002	SUPPL-9	Labeling		Label is not available on this site.
10/29/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/13/1999	SUPPL-7	Labeling		Label is not available on this site.
07/09/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/12/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/13/1996	SUPPL-3	Labeling		Label is not available on this site.
12/09/1991	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
08/20/1991	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 019790

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2014	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdf