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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203208
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;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
07/12/2013 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
10/19/2020 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-4 REMS - PROPOSAL - D-N-A

Label is not available on this site.

10/19/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/04/2014 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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