Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020067
Company: ATNAHS PHARMA US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EC-NAPROSYN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes Yes
EC-NAPROSYN NAPROXEN 500MG TABLET, DELAYED 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
10/14/1994 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
07/22/2019 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017581Orig1s114, 018164Orig1s064, 020067Orig1s021ltr.pdf
03/10/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017581Orig1s113,018164Orig1s063,020067Orig1s020ltr.pdf
05/09/2016 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf
03/22/2013 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf
07/25/2008 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf
09/20/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf
04/19/2007 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf
01/24/2006 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf
03/10/2006 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010ltr.pdf
02/22/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/09/2001 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/10/2004 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf
05/19/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20067slr005ltr.pdf
11/10/2004 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf
07/09/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/28/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/06/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/22/2019 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf
03/10/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf
05/09/2016 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf
05/09/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf
03/22/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf
07/25/2008 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf
09/20/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf
03/10/2006 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf
01/24/2006 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf
11/10/2004 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf
11/10/2004 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf

EC-NAPROSYN

TABLET, DELAYED RELEASE;ORAL; 375MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EC-NAPROSYN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020067 ATNAHS PHARMA US
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091432 INVAGEN PHARMS
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075337 PLIVA
NAPROXEN NAPROXEN 375MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075227 TEVA

TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EC-NAPROSYN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020067 ATNAHS PHARMA US
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 091432 INVAGEN PHARMS
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075337 PLIVA
NAPROXEN NAPROXEN 500MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075227 TEVA

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