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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020353
Company: TWI PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPRELAN NAPROXEN SODIUM EQ 375MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
NAPRELAN NAPROXEN SODIUM EQ 500MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
NAPRELAN NAPROXEN SODIUM EQ 750MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
01/05/1996 ORIG-1 Approval Type 3 - New Dosage Form 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
04/28/2021 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020353Orig1s038ltr.pdf
07/22/2019 SUPPL-36 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020353Orig1s036ltr.pdf
09/06/2017 SUPPL-34 Manufacturing (CMC)-Facility Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020353s034lbl.pdf
05/09/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf
05/09/2016 SUPPL-31 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf
09/12/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
11/08/2011 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020353s028ltr.pdf
07/08/2009 SUPPL-23 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020353s023ltr.pdf
05/29/2007 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020353s019ltr.pdf
01/18/2006 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020353s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020353s016ltr.pdf
04/15/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
10/02/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
06/04/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/15/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/2000 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/20/1999 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/04/2002 SUPPL-8 Labeling

Label is not available on this site.
11/02/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
12/23/1997 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/12/1997 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
01/31/1997 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
01/31/1997 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
03/28/1996 SUPPL-1 Labeling Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020353s001_naprelan_toc.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/28/2021 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf
04/28/2021 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf
07/22/2019 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf
07/22/2019 SUPPL-36 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf
07/22/2019 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf
09/06/2017 SUPPL-34 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020353s034lbl.pdf
05/09/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf
05/09/2016 SUPPL-31 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf
05/09/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf
11/08/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf
07/08/2009 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf
07/08/2009 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf
01/18/2006 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020353s016lbl.pdf

NAPRELAN

TABLET, EXTENDED RELEASE;ORAL; EQ 375MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPRELAN NAPROXEN SODIUM EQ 375MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020353 TWI PHARMS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 375MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075416 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPRELAN NAPROXEN SODIUM EQ 500MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020353 TWI PHARMS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075416 ACTAVIS LABS FL INC

TABLET, EXTENDED RELEASE;ORAL; EQ 750MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPRELAN NAPROXEN SODIUM EQ 750MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 020353 TWI PHARMS
NAPROXEN SODIUM NAPROXEN SODIUM EQ 750MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075416 ACTAVIS LABS FL INC
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