Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076023
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG 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
04/11/2003 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
09/18/2018 SUPPL-19 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/20/2018 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

08/30/2018 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/30/2007 SUPPL-8 Labeling

Label is not available on this site.

04/30/2007 SUPPL-6 Labeling

Label is not available on this site.

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