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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205001
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 300MG;5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;7.5MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 300MG;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
07/05/2016 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205001Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2025 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
10/31/2024 SUPPL-9 REMS - MODIFIED - D-N-A

Label is not available on this site.
12/22/2025 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
12/15/2023 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
03/04/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
10/11/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
09/21/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-2 REMS - PROPOSAL - D-N-A

Label is not available on this site.
04/13/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.
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