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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018976
Company: AUXILIUM PHARMS LLC

Products on NDA 018976

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LEVATOL	PENBUTOLOL SULFATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
LEVATOL	PENBUTOLOL SULFATE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018976

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.

Labels for NDA 018976

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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