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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075280
Company: CHARTWELL RX

Products on ANDA 075280

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075280

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/2002/75280ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75280taltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2021	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-24	Labeling-Medication Guide, Labeling-Patient Package Insert		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.

Therapeutic Equivalents for ANDA 075280

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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