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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091313
Company: MAYNE PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG 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
02/18/2011 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-6 REMS - PROPOSAL - D-N-A

Label is not available on this site.

06/01/2017 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/24/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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