Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021453
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZERIT XR STAVUDINE 37.5MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
ZERIT XR STAVUDINE 50MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
ZERIT XR STAVUDINE 75MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
ZERIT XR STAVUDINE 100MG CAPSULE, 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
12/31/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21453_Zerit_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21453ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021453_s000_ZeritTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2005 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21453s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21453s004ltr.pdf
06/04/2004 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21453slr003_zerit_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21453slr003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/19/2005 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21453s004lbl.pdf
06/04/2004 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21453slr003_zerit_lbl.pdf
12/31/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21453_Zerit_lbl.pdf

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