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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207333
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;5MG TABLET;ORAL Discontinued None No No
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;10MG 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
09/25/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207333Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-3 REMS - PROPOSAL - D-N-A

Label is not available on this site.

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