Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040260
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE 325MG;4.5MG;0.38MG TABLET;ORAL Discontinued None 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
07/17/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40260ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/20/2018 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-15 REMS - PROPOSAL - D-N-A

Label is not available on this site.

03/07/2017 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/24/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/2001 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

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