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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089805
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;30MG TABLET;ORAL Prescription AA 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
10/31/2024 SUPPL-41 REMS - MODIFIED - D-N-A

Label is not available on this site.

12/15/2023 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

10/07/2019 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-31 REMS - PROPOSAL - D-N-A

Label is not available on this site.

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

Label is not available on this site.

12/16/2016 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-26 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

02/11/2008 SUPPL-12 Labeling

Label is not available on this site.

10/18/2007 SUPPL-10 Labeling

Label is not available on this site.

01/10/2007 SUPPL-7 Labeling

Label is not available on this site.

03/16/1995 SUPPL-3 Labeling

Label is not available on this site.

ACETAMINOPHEN AND CODEINE PHOSPHATE

TABLET;ORAL; 300MG;30MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040779 AMNEAL PHARMS NY
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 212418 ELITE LABS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040419 SPECGX LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 089805 STRIDES PHARMA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 211610 WES PHARMA INC
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