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FDA NDA · NDA204485

VASOSTRICT

vasopressin

Sponsor: PH HEALTH

APPLICATION
NDA204485
TYPE
NDA
ORIGINAL APPROVAL
2014-04-17
LATEST ACTION
2023-04-12
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

VASOSTRICT · ReferenceDiscontinued
VASOPRESSIN 50UNITS/50ML (1UNITS/ML) · SOLUTION · INTRAVENOUS
VASOSTRICT · ReferenceDiscontinued
VASOPRESSIN 60UNITS/100ML (0.6UNITS/ML) · SOLUTION · INTRAVENOUS
VASOSTRICT · ReferencePrescription
VASOPRESSIN 200UNITS/10ML (20UNITS/ML) · SOLUTION · INTRAVENOUS
VASOSTRICT · ReferencePrescription
VASOPRESSIN 20UNITS/100ML (0.2UNITS/ML) · SOLUTION · INTRAVENOUS
VASOSTRICT · ReferencePrescription
VASOPRESSIN 40UNITS/100ML (0.4UNITS/ML) · SOLUTION · INTRAVENOUS
VASOSTRICT · ReferencePrescription
VASOPRESSIN 20UNITS/ML (20UNITS/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-04-12Manufacturing (CMC) · Supplement 30 — Label ↗AP
2022-12-06Labeling · Supplement 27 · standard — Letter ↗AP
2022-11-22Labeling · Supplement 26 · standard — Letter ↗AP
2022-09-14Labeling · Supplement 25 · standard — Letter ↗AP
2021-04-21Manufacturing (CMC) · Supplement 20 — Letter ↗AP
2021-03-26Labeling · Supplement 11 · standard — Label ↗AP
2021-03-15Labeling · Supplement 17 · standard — Label ↗AP
2020-04-15Manufacturing (CMC) · Supplement 13 · standard — Label ↗AP
2020-02-21Labeling · Supplement 14 · standard — Letter ↗AP
2019-05-14Labeling · Supplement 9 · standard — Letter ↗AP
2016-12-17Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2016-03-21Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
2015-05-07Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2014-09-18Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2014-04-17Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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