Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021920
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE;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
02/17/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021920s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021920s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021920s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/20/2019 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021920Orig1s023ltr.pdf
11/29/2018 SUPPL-22 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021920Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021920Orig1s022ltr.pdf
03/16/2017 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021920Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021920Orig1s019ltr.pdf
04/01/2013 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021920Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021920Orig1s018ltr.pdf
06/13/2012 SUPPL-17 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021920s017ltr.pdf
08/12/2010 SUPPL-13 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021920s013ltr.pdf
07/14/2009 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021920s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s011ltr.pdf
04/15/2009 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021920s010ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/20/2019 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021920Orig1s023lbl.pdf
11/29/2018 SUPPL-22 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021920Orig1s022lbl.pdf
03/16/2017 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021920Orig1s019lbl.pdf
04/01/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021920Orig1s018lbl.pdf
07/14/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021920s011lbl.pdf
02/17/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021920s000lbl.pdf

NAPROXEN SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; EQ 200MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE;ORAL Over-the-counter Yes 021920 BIONPHARMA INC
NAPROXEN SODIUM NAPROXEN SODIUM EQ 200MG BASE CAPSULE;ORAL Over-the-counter No 208363 PURACAP PHARM LLC

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