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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075189
Company: IMPAX LABS INC

Products on ANDA 075189

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NABUMETONE	NABUMETONE	500MG	TABLET;ORAL	Discontinued	None	No	No
NABUMETONE	NABUMETONE	750MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075189

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
04/28/2021	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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

Labels for ANDA 075189

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

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