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Drugs@FDA: FDA-Approved Drugs

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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 AP Yes Yes
VASOSTRICT VASOPRESSIN 200UNITS/10ML (20UNITS/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VASOSTRICT VASOPRESSIN 40UNITS/100ML (0.4UNITS/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VASOSTRICT VASOPRESSIN 60UNITS/100ML (0.6UNITS/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VASOSTRICT VASOPRESSIN 20UNITS/100ML (0.2UNITS/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
12/06/2022 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204485Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204485Orig1s027ltr.pdf
11/22/2022 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204485Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204485Orig1s026ltr.pdf
09/14/2022 SUPPL-25 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204485Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204485Orig1s025ltr.pdf
04/21/2021 SUPPL-20 Manufacturing (CMC)-Manufacturing Process Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204485Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204485Orig1s020ltr.pdf
03/15/2021 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204485Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204485Orig1s017ltr.pdf
02/21/2020 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204485s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204485Orig1s014ltr.pdf
04/15/2020 SUPPL-13 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204485Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204485Orig1s013ltr.pdf
03/26/2021 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204485s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204485Orig1s011ltr.pdf
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
12/06/2022 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204485Orig1s027lbl.pdf
11/22/2022 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204485Orig1s026lbl.pdf
09/14/2022 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204485Orig1s025lbl.pdf
04/21/2021 SUPPL-20 Manufacturing (CMC)-Manufacturing Process Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204485Orig1s020lbl.pdf
03/26/2021 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204485s011lbl.pdf
03/15/2021 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204485Orig1s017lbl.pdf
04/15/2020 SUPPL-13 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204485Orig1s013lbl.pdf
02/21/2020 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204485s014lbl.pdf
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

VASOSTRICT

SOLUTION;INTRAVENOUS; 20UNITS/ML (20UNITS/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VASOPRESSIN VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION;INTRAVENOUS Prescription No AP 212944 AMNEAL
VASOPRESSIN VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION;INTRAVENOUS Prescription No AP 211857 AMPHASTAR PHARMS INC
VASOPRESSIN VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION;INTRAVENOUS Prescription No AP 211538 EAGLE PHARMS
VASOPRESSIN VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION;INTRAVENOUS Prescription No AP 214314 EUGIA PHARMA
VASOSTRICT VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 204485 PAR STERILE PRODUCTS
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