Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017581
Company: ATNAHS PHARMA US
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 |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-117 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581s117,018164s067,020067s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017581Orig1s117,018164Orig1s067,020067Orig1s026ltr.pdf | |
| 05/13/2024 | SUPPL-116 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581Orig1s116, 018164Orig1s066, 020067Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017581Orig1s116, 018164Orig1s066, 020067Orig1s025ltr.pdf | |
| 04/28/2021 | SUPPL-115 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017581Orig1s115; 018164Orig1s065; 020067Orig1s024ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-117 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581s117,018164s067,020067s026lbl.pdf | |
| 05/13/2024 | SUPPL-116 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581Orig1s116, 018164Orig1s066, 020067Orig1s025lbl.pdf | |
| 05/13/2024 | SUPPL-116 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581Orig1s116, 018164Orig1s066, 020067Orig1s025lbl.pdf | |
| 04/28/2021 | SUPPL-115 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s064lbl.pdf | |
| 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 | 091416 | ADAPTIS |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 075927 | AMNEAL PHARMS NY |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 200429 | AUROBINDO PHARMA |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 078250 | GLENMARK PHARMS LTD |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 074140 | GRANULES |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 212517 | SCIEGEN PHARMS INC |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 074201 | TEVA |
| NAPROXEN | NAPROXEN | 500MG | TABLET;ORAL | Prescription | No | AB | 078620 | ZYDUS PHARMS USA |