Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021076
Company: BAYER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALEVE-D SINUS & COLD NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE 200MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter 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
11/29/1999 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21076ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2017 SUPPL-15 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021076Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021076Orig1s015ltr.pdf
04/17/2009 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021076s014ltr.pdf
08/04/2008 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021076s013ltr.pdf
01/06/2006 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021076s011ltr.pdf
07/31/2002 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21076slr007LTR.pdf
12/21/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/15/2000 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
09/12/2017 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021076Orig1s015lbl.pdf
11/29/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-076_Aleve_prntlbl.pdf

ALEVE-D SINUS & COLD

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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