Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020067
Company: ATNAHS PHARMA US
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 |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-26 | 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-25 | 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-24 | 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-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 |
|---|---|---|---|---|---|
| 11/21/2024 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581s117,018164s067,020067s026lbl.pdf | |
| 05/13/2024 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581Orig1s116, 018164Orig1s066, 020067Orig1s025lbl.pdf | |
| 05/13/2024 | SUPPL-25 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581Orig1s116, 018164Orig1s066, 020067Orig1s025lbl.pdf | |
| 04/28/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017581s115,018164s065,020067s024lbl.pdf | |
| 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 | 075390 | AUROBINDO PHARMA USA |
| NAPROXEN | NAPROXEN | 375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 218497 | NOVITIUM PHARMA |
| NAPROXEN | NAPROXEN | 375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091432 | NUVO PHARMS INC |
| NAPROXEN | NAPROXEN | 375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075227 | TEVA |
| NAPROXEN | NAPROXEN | 375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 216908 | TP ANDA HOLDINGS |
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 | 075390 | AUROBINDO PHARMA USA |
| NAPROXEN | NAPROXEN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 218497 | NOVITIUM PHARMA |
| NAPROXEN | NAPROXEN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 091432 | NUVO PHARMS INC |
| NAPROXEN | NAPROXEN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075227 | TEVA |
| NAPROXEN | NAPROXEN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 216908 | TP ANDA HOLDINGS |