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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089828
Company: STRIDES PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG 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
09/30/1988 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
12/15/2023 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-29 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2016 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

02/11/2008 SUPPL-10 Labeling

Label is not available on this site.

10/18/2007 SUPPL-8 Labeling

Label is not available on this site.

01/10/2007 SUPPL-6 Labeling

Label is not available on this site.

03/16/1995 SUPPL-2 Labeling

Label is not available on this site.

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