An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 204485
Company: ENDO OPERATIONS

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	Discontinued	None	Yes	No
VASOSTRICT	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
VASOSTRICT	VASOPRESSIN	50UNITS/50ML (1UNITS/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

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	213988	DR REDDYS
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
VASOPRESSIN	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216963	GLAND
VASOSTRICT	VASOPRESSIN	20UNITS/ML (20UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204485	ENDO OPERATIONS

SOLUTION;INTRAVENOUS; 20UNITS/100ML (0.2UNITS/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VASOPRESSIN	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217987	CIPLA
VASOSTRICT	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	204485	ENDO OPERATIONS

Top