Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019806
Company: AUXILIUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SEMPREX-D ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE 8MG;60MG CAPSULE;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
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.

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

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