Drugs@FDA: FDA-Approved Drugs
Company: TWI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPRELAN | NAPROXEN SODIUM | EQ 375MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
NAPRELAN | NAPROXEN SODIUM | EQ 500MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
NAPRELAN | NAPROXEN SODIUM | EQ 750MG BASE | TABLET, EXTENDED 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 |
---|---|---|---|---|---|---|---|
01/05/1996 | 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 |
---|---|---|---|---|---|
04/28/2021 | SUPPL-38 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020353Orig1s038ltr.pdf | |
07/22/2019 | SUPPL-36 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020353Orig1s036ltr.pdf | |
09/06/2017 | SUPPL-34 | Manufacturing (CMC)-Facility |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020353s034lbl.pdf | |
05/09/2016 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf | |
05/09/2016 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf | |
09/12/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/08/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020353s028ltr.pdf | |
07/08/2009 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020353s023ltr.pdf | |
05/29/2007 | SUPPL-19 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020353s019ltr.pdf |
01/18/2006 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020353s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020353s016ltr.pdf | |
04/15/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/02/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/04/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/15/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/15/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/20/1999 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/04/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
11/02/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/23/1997 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
05/12/1997 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
01/31/1997 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
01/31/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/28/1996 | SUPPL-1 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020353s001_naprelan_toc.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf | |
04/28/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020353s038lbl.pdf | |
07/22/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf | |
07/22/2019 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf | |
07/22/2019 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020353s036lbl.pdf | |
09/06/2017 | SUPPL-34 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020353s034lbl.pdf | |
05/09/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf | |
05/09/2016 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf | |
05/09/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf | |
11/08/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf | |
07/08/2009 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf | |
07/08/2009 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf | |
01/18/2006 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020353s016lbl.pdf |
NAPRELAN
TABLET, EXTENDED RELEASE;ORAL; EQ 375MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NAPRELAN | NAPROXEN SODIUM | EQ 375MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020353 | TWI PHARMS |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 375MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075416 | ACTAVIS LABS FL INC |
TABLET, EXTENDED RELEASE;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NAPRELAN | NAPROXEN SODIUM | EQ 500MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020353 | TWI PHARMS |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075416 | ACTAVIS LABS FL INC |
TABLET, EXTENDED RELEASE;ORAL; EQ 750MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NAPRELAN | NAPROXEN SODIUM | EQ 750MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020353 | TWI PHARMS |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 750MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075416 | ACTAVIS LABS FL INC |