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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091670
Company: MAYNE PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ASPIRIN ASPIRIN; OXYCODONE HYDROCHLORIDE 325MG;4.8355MG 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
03/16/2011 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
04/28/2021 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/26/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/20/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-2 REMS - PROPOSAL - D-N-A

Label is not available on this site.

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