Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021640
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VITRASE HYALURONIDASE 6,200 UNITS/VIAL INJECTABLE;INJECTION Discontinued None No No
VITRASE HYALURONIDASE 200 UNITS/VIAL INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/05/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640_vitrase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-640_Vitrase.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2018 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021640s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021640Orig1s025ltr.pdf
02/16/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/30/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/11/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/12/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021640s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021640s016ltr.pdf
12/02/2004 SUPPL-3 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf
12/02/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf
12/21/2004 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/25/2018 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021640s025lbl.pdf
04/12/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021640s016lbl.pdf
12/21/2004 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s001lbl.pdf
12/02/2004 SUPPL-3 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf
12/02/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf
05/05/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640_vitrase_lbl.pdf

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