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VASOPRESSIN

ANDA

VASOPRESSIN | A211857 | AMPHASTAR PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VASOSTRICT(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Par Pharmaceutical, Inc. et al v. Amneal Pharmaceuticals of New York, LLC, et al., 1:2018cv02032 6 patentsANDA 211857Vasopressin	D. Del.	2018-12-20	Terminated 2022-02-09	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

4 petitions (4 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 2 Labeling for the RLD, Vasostrict® (Vasopressin Injection USP), ... FDA-2020-P-2077 The Weinberg Group LLC filed a suitability petition regarding Vasostrict (Vasopressin Injection USP), 20 Units/mL, the reference listed drug approved under NDA 204485. The petition addresses the suitability of the reference labeling for use in evaluating generic ANDA applications for vasopressin inj	Suitability	2020-10-15	Open	The Weinberg Group LLC
Attachment 3 Proposed Prescribing Information for Vasopressin Injection USP, ... FDA-2020-P-2077 This document contains proposed prescribing information for vasopressin injection in two formulations (50 units/2.5 mL and 100 units/5 mL single dose vials) submitted by The Weinberg Group LLC as part of a suitability petition to the FDA regarding the appropriate regulatory pathway and requirements	Suitability	2020-10-15	Open	The Weinberg Group LLC
Attachment 3 Proposed Prescribing Information for Vasopressin Injection USP, ... FDA-2020-P-1766 The Weinberg Group LLC filed a suitability petition requesting FDA approval of proposed prescribing information for vasopressin injection USP in two formulations: 50 units/2.5 mL and 100 units/5 mL in single dose vials. The petition seeks to establish the suitability of these vasopressin injection p	Suitability	2020-08-18	Open	The Weinberg Group LLC
Attachment 2 Labeling for the RLD, Vasostrict® (Vasopressin Injection USP), 2... FDA-2020-P-1766 The Weinberg Group LLC filed a suitability petition regarding Vasostrict (Vasopressin Injection USP), 20 Units/mL, approved under NDA 204485, requesting FDA evaluation of the reference listed drug's labeling suitability for use as a reference standard for generic vasopressin injection applications.	Suitability	2020-08-18	Open	The Weinberg Group LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain7 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

BCN PEPTIDES SAVASOPRESSIN

DMF 257362012

POLYPEPTIDE LABORATORIES SWEDEN ABVASOPRESSIN

DMF 321162017

PIRAMAL PHARMA LTDVASOPRESSIN USP

DMF 321462017

INTERNATIONAL MEDICATION SYSTEMS LTDVASOPRESSIN USP

DMF 327692018

AURO PEPTIDES LTDVASOPRESSIN USP

DMF 331192018

HAINAN SHUANGCHENG PHARMACEUTICALS CO LTDVASOPRESSIN USP

DMF 376342022

HETERO DRUGS LTDVASOPRESSIN USP

DMF 420732025

POLYPEPTIDE LABORATORIES SWEDEN ABInactiveVASOPRESSIN

DMF 275772013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 12, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20UNITS/ML (20UNITS/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 18, 2022

No patent or exclusivity listings for this strength.