Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204485
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASOSTRICT VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VASOSTRICT VASOPRESSIN 200UNITS/10ML (20UNITS/ML) SOLUTION;INTRAVENOUS 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
04/17/2014 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204485Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204485Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2019 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204485s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204485Orig1s009ltr.pdf
12/17/2016 SUPPL-4 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204485Orig1s004.pdf
03/21/2016 SUPPL-3 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/2044850Orig1s003.pdf
05/07/2015 SUPPL-2 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204485Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204485Orig1s002ltr.pdf
09/18/2014 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/14/2019 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204485s009lbl.pdf
12/17/2016 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s004lbl.pdf
03/21/2016 SUPPL-3 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s003lbl.pdf
05/07/2015 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204485Orig1s002lbl.pdf
09/18/2014 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s001lbl.pdf
04/17/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204485Orig1s000lbl.pdf

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