Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078316
Company: BARR LABS INC
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 Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/29/2007 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-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-8 REMS - PROPOSAL - D-N-A

Label is not available on this site.

02/28/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/18/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

OXYCODONE HYDROCHLORIDE AND IBUPROFEN

TABLET;ORAL; 400MG;5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXYCODONE HYDROCHLORIDE AND IBUPROFEN IBUPROFEN; OXYCODONE HYDROCHLORIDE 400MG;5MG TABLET;ORAL Prescription No AB 078769 ACTAVIS ELIZABETH
OXYCODONE HYDROCHLORIDE AND IBUPROFEN IBUPROFEN; OXYCODONE HYDROCHLORIDE 400MG;5MG TABLET;ORAL Prescription No AB 078316 BARR LABS INC

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