Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075416
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
09/08/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

04/15/2015 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert, 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 ALVOGEN
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 ALVOGEN
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 ALVOGEN
NAPROXEN SODIUM NAPROXEN SODIUM EQ 750MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075416 ACTAVIS LABS FL INC

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