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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204085
Company: CHARTWELL MOLECULAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 100MG/5ML SOLUTION;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
09/10/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204085Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2020 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/05/2020 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2018 SUPPL-4 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/25/2015 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

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