Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040650
Company: PHARM ASSOC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE WITH CODEINE CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 10MG/5ML;6.25MG/5ML SYRUP;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
01/31/2006 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
06/28/2018 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

06/19/2018 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/29/2017 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/29/2017 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/13/2017 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

09/08/2009 SUPPL-6 Labeling

Label is not available on this site.

12/19/2008 SUPPL-3 Labeling

Label is not available on this site.

02/25/2008 SUPPL-2 Labeling

Label is not available on this site.

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