An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021076
Company: BAYER

Other Important Information from FDA

Products on NDA 021076

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALEVE-D SINUS & COLD	NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE	220MG;120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021076

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
07/11/2023	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021076Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021076Orig1s019ltr.pdf
03/02/2022	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021076Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021076Orig1s017ltr.pdf
04/06/2020	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021076Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021076Orig1s016ltr.pdf
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.

Labels for NDA 021076

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2023	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021076Orig1s019lbl.pdf
03/02/2022	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021076Orig1s017lbl.pdf
04/06/2020	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021076Orig1s016lbl.pdf
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

Top