Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078769
Company: ACTAVIS ELIZABETH
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 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
01/04/2008 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
10/08/2019 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/22/2019 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-22 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/15/2018 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

12/16/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/02/2011 SUPPL-8 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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