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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075855
Company: DR REDDYS LABS LTD
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
01/31/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75855ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/11/2019 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/11/2019 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/31/2006 SUPPL-5 Labeling

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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