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Abbreviated New Drug Application (ANDA): 040355
Company: STRIDES PHARMA INTL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 325MG;10MG 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
05/31/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40355ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2025 SUPPL-46 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/31/2024 SUPPL-45 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/22/2025 SUPPL-44 Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/15/2023 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-42 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/11/2019 SUPPL-41 Labeling-Package Insert

Label is not available on this site.
10/11/2019 SUPPL-39 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
09/21/2018 SUPPL-36 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-35 REMS - PROPOSAL - D-N-A

Label is not available on this site.
12/16/2016 SUPPL-34 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-31 Labeling-Package Insert

Label is not available on this site.
12/15/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
12/16/2016 SUPPL-29 Labeling-Package Insert

Label is not available on this site.
12/15/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.
12/15/2016 SUPPL-22 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
10/22/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.
07/01/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
07/08/2003 SUPPL-4 Labeling

Label is not available on this site.
11/18/2002 SUPPL-2 Labeling

Label is not available on this site.
06/06/2002 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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