Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018164
Company: ATNAHS PHARMA US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANAPROX NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Prescription AB Yes No
ANAPROX DS NAPROXEN SODIUM EQ 500MG BASE 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
09/04/1980 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
03/10/2017 SUPPL-63 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-62 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-61 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-60 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-58 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-57 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-56 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-55 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-54 Manufacturing (CMC)

Label is not available on this site.

11/09/2001 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/08/2000 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

11/10/2004 SUPPL-51 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-50 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-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf
09/06/1994 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-47 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/15/1993 SUPPL-46 Labeling

Label is not available on this site.

08/12/1992 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/08/1992 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/1990 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1987 SUPPL-36 Efficacy-New Indication

Label is not available on this site.

09/30/1987 SUPPL-35 Efficacy-New Dosing Regimen

Label is not available on this site.

09/30/1987 SUPPL-34 Labeling

Label is not available on this site.

06/10/1986 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/24/1985 SUPPL-31 Labeling

Label is not available on this site.

05/03/1985 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/30/1987 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/29/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/09/1983 SUPPL-21 Labeling

Label is not available on this site.

08/29/1986 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1983 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1982 SUPPL-17 Labeling

Label is not available on this site.

12/07/1982 SUPPL-16 Labeling

Label is not available on this site.

09/30/1987 SUPPL-15 Labeling

Label is not available on this site.

04/23/1985 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/18/1982 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1983 SUPPL-12 Labeling

Label is not available on this site.

04/22/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/22/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/22/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/10/1982 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/1982 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/1982 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/13/1981 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1981 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
03/10/2017 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf
05/09/2016 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf
05/09/2016 SUPPL-62 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf
03/22/2013 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf
07/25/2008 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf
09/20/2007 SUPPL-58 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf
03/10/2006 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf
01/24/2006 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf
11/10/2004 SUPPL-51 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-50 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf

ANAPROX

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAPROX NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Prescription Yes AB 018164 ATNAHS PHARMA US
NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 078432 AMNEAL PHARMS NY
NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 200629 AUROBINDO PHARMA LTD
NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 078486 DR REDDYS LABS LTD
NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 078314 GLENMARK PHARMS LTD
NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET;ORAL Prescription No AB 074198 TEVA

ANAPROX DS

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ANAPROX DS NAPROXEN SODIUM EQ 500MG BASE TABLET;ORAL Prescription Yes AB 018164 ATNAHS PHARMA US
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 078432 AMNEAL PHARMS NY
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 200629 AUROBINDO PHARMA LTD
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 078486 DR REDDYS LABS LTD
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 078314 GLENMARK PHARMS LTD
NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET;ORAL Prescription No AB 074198 TEVA

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