Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078394
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE AND IBUPROFEN IBUPROFEN; OXYCODONE HYDROCHLORIDE 400MG;5MG 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
11/26/2007 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
09/21/2018 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.

05/24/2019 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

12/16/2016 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

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