Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 500MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 375MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 750MG BASE | TABLET, EXTENDED 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 |
---|---|---|---|---|---|---|---|
08/27/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075416Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/22/2024 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
11/25/2019 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/08/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
04/15/2015 | SUPPL-12 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
02/21/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
04/03/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
04/23/2003 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/23/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/21/2003 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
NAPROXEN SODIUM
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 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 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 |