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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078671
Company: INVAGEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription AB No No
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription AB No 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
03/07/2008 ORIG-1 Approval

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-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/28/2021 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/09/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

NABUMETONE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 090445 ANNORA PHARMA
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 076009 CHARTWELL MOLECULES
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 075280 CHARTWELL RX
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 078671 INVAGEN PHARMS
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 203166 LGM PHARMA
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 078420 SCIEGEN PHARMS INC
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 091083 WATSON LABS

TABLET;ORAL; 750MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 090445 ANNORA PHARMA
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 076009 CHARTWELL MOLECULES
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 075280 CHARTWELL RX
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 078671 INVAGEN PHARMS
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 203166 LGM PHARMA
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 078420 SCIEGEN PHARMS INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 091083 WATSON LABS
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