Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075189
Company: IMPAX LABS 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 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
05/26/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75189AP-TA.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75189ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/10/2009 SUPPL-18 Labeling

Label is not available on this site.

05/19/2006 SUPPL-16 Labeling

Label is not available on this site.

03/17/2006 SUPPL-14 Labeling

Label is not available on this site.

03/02/2006 SUPPL-12 Labeling

Label is not available on this site.

05/21/2002 SUPPL-4 Labeling

Label is not available on this site.

06/21/2002 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/24/2001 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf
09/24/2001 SUPPL-1 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75189S01ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/26/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-189_Nabumetone_prntlbl.pdf

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 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 203166 NEXGEN PHARMA INC
NABUMETONE NABUMETONE 500MG TABLET;ORAL Prescription No AB 090427 NOSTRUM LABS INC
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 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 203166 NEXGEN PHARMA INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 090427 NOSTRUM LABS INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 078420 SCIEGEN PHARMS INC
NABUMETONE NABUMETONE 750MG TABLET;ORAL Prescription No AB 091083 WATSON LABS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English