Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075656
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MORPHINE SULFATE MORPHINE SULFATE 100MG 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
01/30/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75656ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075656.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2015 SUPPL-7 Labeling-Package Insert, REMS-Modified

Label is not available on this site.

10/10/2003 SUPPL-4 Labeling

Label is not available on this site.

07/15/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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