Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019790
Company: AUXILIUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILATRATE-SR ISOSORBIDE DINITRATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
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.

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

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