Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018976
Company: AUXILIUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVATOL PENBUTOLOL SULFATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LEVATOL PENBUTOLOL SULFATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/30/1987 ORIG-1 Approval Type 1 - New Molecular Entity 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
05/03/2011 SUPPL-12 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018976s012lbl.pdf
02/06/2001 SUPPL-9 Labeling

Label is not available on this site.

09/25/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/29/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/07/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/12/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/15/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/07/1990 SUPPL-3 Labeling

Label is not available on this site.

01/05/1989 SUPPL-2 Labeling

Label is not available on this site.

10/26/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2011 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018976s012lbl.pdf

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