Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040061
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROXILOX ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 500MG;5MG CAPSULE;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
07/03/1995 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
08/14/2001 SUPPL-8 Labeling

Label is not available on this site.

04/26/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/2001 SUPPL-6 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/22/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/19/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/19/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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