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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040535
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 325MG;7.5MG 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
09/05/2003 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
03/04/2021 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-33 REMS - PROPOSAL - D-N-A

Label is not available on this site.

09/21/2018 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-31 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

07/19/2011 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/19/2008 SUPPL-17 Labeling

Label is not available on this site.

03/20/2008 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

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