Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208633
Company: AMNEAL PHARMS CO

Products on ANDA 208633

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXAPROZIN	OXAPROZIN	600MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208633

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2022	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/07/2022	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/07/2022	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208633

OXAPROZIN

TABLET;ORAL; 600MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAYPRO	OXAPROZIN	600MG	TABLET;ORAL	Prescription	Yes	AB	018841	PFIZER
OXAPROZIN	OXAPROZIN	600MG	TABLET;ORAL	Prescription	No	AB	208633	AMNEAL PHARMS CO
OXAPROZIN	OXAPROZIN	600MG	TABLET;ORAL	Prescription	No	AB	075987	CHARTWELL
OXAPROZIN	OXAPROZIN	600MG	TABLET;ORAL	Prescription	No	AB	075855	DR REDDYS LABS LTD
OXAPROZIN	OXAPROZIN	600MG	TABLET;ORAL	Prescription	No	AB	075845	SANDOZ