ALEVE-D SINUS & COLD از شرکت BAYER

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALEVE-D SINUS & COLD از شرکت BAYER

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 220MG;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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ALEVE-D SINUS & COLD

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

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