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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204485
Company: PAR STERILE PRODUCTS

Summary Review

Products on NDA 204485

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
VASOSTRICT	VASOPRESSIN	50UNITS/50ML (1UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204485

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
04/12/2023	SUPPL-30	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204485Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204485Orig1s030ltr.pdf
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) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204485Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204485Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/204485Orig1s020.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) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204485Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204485Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/204485Orig1s013.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

Labels for NDA 204485

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2023	SUPPL-30	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204485Orig1s030lbl.pdf
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

Therapeutic Equivalents for NDA 204485

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
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213206	FRESENIUS KABI USA
VASOSTRICT	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204485	PAR STERILE PRODUCTS

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