Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040255
Company: ANI PHARMS INC
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
02/27/1998 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40255ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/08/2019 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-27 REMS - PROPOSAL - D-N-A

Label is not available on this site.

06/29/2017 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-25 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/13/2004 SUPPL-6 Labeling

Label is not available on this site.

03/21/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

08/21/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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