Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040688
Company: WRASER PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 356.4MG;30MG;16MG CAPSULE;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
04/03/2007 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
11/24/2008 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2008 SUPPL-1 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

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