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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202142
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 300MG/5ML;10MG/5ML SOLUTION;ORAL Prescription 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
11/27/2018 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202142Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/29/2020 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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