Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017581
Company: ATNAHS PHARMA US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROSYN NAPROXEN 250MG TABLET;ORAL Discontinued None Yes No
NAPROSYN NAPROXEN 375MG TABLET;ORAL Discontinued None Yes No
NAPROSYN NAPROXEN 500MG TABLET;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
03/11/1976 ORIG-1 Approval Type 1 - New Molecular Entity 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-114 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-113 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/2017/017581Orig1s113,018161Orig1s063,020067Orig1s020ltr.pdf
05/09/2016 SUPPL-112 Labeling-Package Insert, Labeling-Medication Guide 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-111 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-110 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-108 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-107 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-106 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-105 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/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf
02/22/2002 SUPPL-103 Manufacturing (CMC)

Label is not available on this site.

11/09/2001 SUPPL-102 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/08/2000 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

11/10/2004 SUPPL-100 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
11/10/2004 SUPPL-99 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
04/14/2003 SUPPL-98 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf
12/08/1994 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

03/28/1994 SUPPL-96 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/12/1994 SUPPL-95 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1992 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

05/08/1992 SUPPL-89 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/16/1991 SUPPL-88 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/21/1994 SUPPL-87 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/30/1991 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1989 SUPPL-80 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/23/1987 SUPPL-73 Efficacy-New Indication

Label is not available on this site.

12/16/1986 SUPPL-72 Labeling

Label is not available on this site.

09/24/1985 SUPPL-69 Labeling

Label is not available on this site.

06/10/1986 SUPPL-68 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/17/1986 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1987 SUPPL-65 Efficacy-New Dosing Regimen

Label is not available on this site.

04/23/1985 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

12/16/1986 SUPPL-63 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/23/1985 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

04/29/1985 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

09/09/1983 SUPPL-54 Labeling

Label is not available on this site.

04/23/1985 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1988 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

12/03/1982 SUPPL-50 Labeling

Label is not available on this site.

12/03/1982 SUPPL-49 Labeling

Label is not available on this site.

01/13/1983 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1983 SUPPL-46 Labeling

Label is not available on this site.

03/31/1982 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

03/31/1982 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/1982 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/13/1981 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1981 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1981 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1982 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/02/1981 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1981 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/13/1981 SUPPL-34 Labeling

Label is not available on this site.

10/13/1981 SUPPL-33 Labeling

Label is not available on this site.

04/15/1982 SUPPL-31 Labeling

Label is not available on this site.

09/12/1980 SUPPL-30 Labeling

Label is not available on this site.

05/13/1980 SUPPL-27 Labeling

Label is not available on this site.

03/21/1980 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1980 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/09/1979 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/1979 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/06/1979 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/17/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1979 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1979 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/02/1978 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/24/1979 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1978 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1979 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/02/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/15/1980 SUPPL-4 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017581_S004_NAPROSYN_AP.pdf
11/29/1976 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/13/1976 SUPPL-2 Labeling

Label is not available on this site.

07/15/1980 SUPPL-1 Efficacy

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-114 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf
03/10/2017 SUPPL-113 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf
05/09/2016 SUPPL-112 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf
05/09/2016 SUPPL-112 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf
03/22/2013 SUPPL-111 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf
07/25/2008 SUPPL-110 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf
09/20/2007 SUPPL-108 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf
03/10/2006 SUPPL-105 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf
01/24/2006 SUPPL-106 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf
11/10/2004 SUPPL-100 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-99 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf

NAPROSYN

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAPROSYN NAPROXEN 500MG TABLET;ORAL Prescription Yes AB 017581 ATNAHS PHARMA US
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 075927 AMNEAL PHARMS NY
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 200429 AUROBINDO PHARMA LTD
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 078250 GLENMARK GENERICS
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 091305 INVAGEN PHARMS
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 091416 MARKSANS PHARMA
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 074121 MYLAN
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 077339 PERRIGO PHARMS CO
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 074201 TEVA
NAPROXEN NAPROXEN 500MG TABLET;ORAL Prescription No AB 078620 ZYDUS PHARMS USA

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