Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019806
Company: AUXILIUM PHARMS LLC

Products on NDA 019806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SEMPREX-D	ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE	8MG;60MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019806

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/1994	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	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
04/11/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019806s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019806Orig1s013ltr.pdf
02/25/2004	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19806slr008ltr.pdf
02/20/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
01/21/2000	SUPPL-4	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/04/1997	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
07/30/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/23/1994	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019806

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019806s013lbl.pdf