Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019977
Company: XANODYNE PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORAMORPH SR MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ORAMORPH SR MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ORAMORPH SR MORPHINE SULFATE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
ORAMORPH SR MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;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
08/15/1991 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2001 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf
11/23/1994 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/13/2001 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19977s4s7ltr.pdf
03/11/1994 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/18/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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