Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088790
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYLOX 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
12/12/1984 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
11/30/2001 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

07/31/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/2002 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

01/24/2001 SUPPL-12 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/03/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/06/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/30/1991 SUPPL-8 Labeling

Label is not available on this site.

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