Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018164
Company: ATNAHS PHARMA US
Company: ATNAHS PHARMA US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANAPROX | NAPROXEN SODIUM | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017581Orig1s115; 018164Orig1s065; 020067Orig1s024ltr.pdf | |
| 07/22/2019 | SUPPL-64 | 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-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-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-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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf | |
| 07/22/2019 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017581s114,018164s064,020067s021lbl.pdf | |
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf | |
| 05/09/2016 | SUPPL-62 | Labeling-Package Insert | 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
There are no Therapeutic Equivalents.
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 | 212199 | SCIEGEN PHARMS INC |