Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN | NAPROXEN | 375MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
NAPROXEN | NAPROXEN | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/30/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75227ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/06/2019 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/06/2019 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
11/06/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
09/02/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
04/25/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
05/19/2006 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
02/17/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
12/02/1999 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/02/1999 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
NAPROXEN
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 | 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 | TULEX PHARMS INC |
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 | 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 | TULEX PHARMS INC |