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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208633
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXAPROZIN OXAPROZIN 600MG 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
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.

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
OXAPROZIN OXAPROZIN 600MG TABLET;ORAL Prescription No AB 075849 TEVA
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