Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077727
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG 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
11/06/2006 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-20 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-17 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/14/2018 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/03/2015 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/23/2013 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/31/2007 SUPPL-1 Labeling

Label is not available on this site.

HYDROCODONE BITARTRATE AND IBUPROFEN

TABLET;ORAL; 5MG;200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Prescription No AB 076642 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Prescription No AB 091633 SUN PHARM INDS INC
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 5MG;200MG TABLET;ORAL Prescription No AB 077727 VINTAGE PHARMS

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