Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204785
Company: WRASER PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TREZIX ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5MG;30MG;16MG CAPSULE;ORAL Prescription 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
11/26/2014 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204785Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204785Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/29/2019 SUPPL-7 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/07/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/26/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204785Orig1s000lbl.pdf

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