Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076604
Company: ACTAVIS LABS FL INC
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 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
12/31/2003 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
09/21/2018 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-20 REMS - PROPOSAL - D-N-A

Label is not available on this site.

03/22/2017 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/22/2017 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/31/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/22/2007 SUPPL-4 Labeling

Label is not available on this site.

HYDROCODONE BITARTRATE AND IBUPROFEN

TABLET;ORAL; 7.5MG;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 7.5MG;200MG TABLET;ORAL Prescription No AB 076604 ACTAVIS LABS FL INC
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 076642 AMNEAL PHARMS NY
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 204575 AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 091633 SUN PHARM INDS INC
HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN 7.5MG;200MG TABLET;ORAL Prescription No AB 077723 VINTAGE PHARMS

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