Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040846
Company: ANDA REPOSITORY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;2.5MG 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
06/09/2010 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
03/05/2021 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/28/2019 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-11 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/24/2018 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/15/2016 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/18/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/040432s006,040556s012,040658s006,040846s005,089699s044ltr.pdf
05/12/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/25/2010 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
10/18/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/040432s006,40556s012,40658s006, 40846s005, 89699s044lbl.pdf

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