Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075280
Company: CASI PHARMS INC
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 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
02/25/2002 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75280taltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75280ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-24 Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/16/2007 SUPPL-12 Labeling

Label is not available on this site.

02/23/2006 SUPPL-11 Labeling

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 090427 APOTEX INC
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 075280 CASI PHARMS INC
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 076009 CHARTWELL MOLECULES
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 075189 IMPAX LABS INC
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 078671 INVAGEN PHARMS
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 090445 LUPIN LTD
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 090516 MYLAN 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 090427 APOTEX INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 075280 CASI PHARMS INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 076009 CHARTWELL MOLECULES
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 075189 IMPAX LABS INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 078671 INVAGEN PHARMS
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 090445 LUPIN LTD
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 090516 MYLAN PHARMS INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 091083 WATSON LABS

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