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ATROPINE SULFATE

NDA

ATROPINE SULFATE | N214652 | ACCORD HEALTHCARE INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Gland Pharma Limited FDA-2026-P-7043 · 3 docket documents Gland Pharma Limited filed this citizen petition requesting that the FDA determine whether Atropine Sulfate Injection, 0.4 mg/mL (NDA 214652), held by Accord Healthcare Inc, was voluntarily withdrawn or withheld from sale for reasons of safety or effectiveness, as required under 21 CFR 314.161 befor	505(q)	2026-06-25	Open	Gland Pharma Limited

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

Clinical Trials

115 trials from ClinicalTrials.gov — 2 recruiting, 4 active, 83 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability NCT02078336	Phase 4	Active	Universitaire Ziekenhuizen KU Leuven	40	2013-12 → 2025-07
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)NCT03140358	Phase 3	Active	Singapore National Eye Centre	300	2017-04-21 → 2025-12-31
Low-dose Atropine for Myopia Control in Children NCT03865160	Phase 2/3	Active	University Eye Hospital, Freiburg	302	2021-10-19 → 2027-11
Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom NCT03690089	Phase 2	Active	Belfast Health and Social Care Trust	289	2019-04-03 → 2027-02-02
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery NCT00992901	Early Phase 1	Recruiting	The University of Texas Health Science Center at San Antonio	160	2009-10 → 2027-08
The Effects of Bariatric Surgeries on Glucose Metabolism NCT02823665	Early Phase 1	Recruiting	The University of Texas Health Science Center at San Antonio	200	2015-07 → 2027-08
An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old NCT00094692	Phase 3	Completed	Jaeb Center for Health Research	507	2002-10 → 2005-12
Remifentanil and Atropine for Intubation in Neonates NCT00815048	Phase 4	Completed	King Saud University	30	2006-01 → 2008-02
A Study of Inhaled Atropine Sulfate in Healthy Adults NCT00947596	Phase 1	Completed	MicroDose Defense Products L.L.C.	18	2009-08 → 2010-08
Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation NCT01427985	Phase 4	Completed	University of Ulm	24	2011-06 → 2012-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain12 active DMFs1 inactive

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

CURIA WISCONSIN INCATROPINE SULFATE, USP

DMF 284232014

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 289782014

ROLABO OUTSOURCING SLATROPINE SULFATE USP

DMF 293962015

SCL LIFESCIENCES LTDATROPINE SULFATE USP

DMF 296052015

RESONANCE LABORATORIES PVT LTDATROPINE SULFATE

DMF 298032015

MINSHENG GROUP SHAOXING PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 302272016

C-SQUARED PHARMA LTDATROPINE SULFATE USP

DMF 306052016

ALCHEM INTERNATIONAL PRIVATE LTDATROPINE SULFATE USP

DMF 312782016

MATRIX PHARMACORP PRIVATE LTDATROPINE SULFATE USP

DMF 322902017

SS PHARMA LLCATROPINE SULFATE MONOHYDRATE USP

DMF 337812019

HENAN PURUI PHARMACEUTICAL CO LTDATROPINE SULFATE

DMF 364842021

FLOWCHEM PHARMA PVT LTDATROPINE SULFATE USP

DMF 422992025

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveATROPINE SULFATE

DMF 54941984

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 5, 2026	SUPPL -5	View Letter (PDF)
Feb 19, 2025	SUPPL -4	View Letter (PDF)
Sep 30, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.4MG/ML (0.4MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Sep 29, 2020

No patent or exclusivity listings for this strength.

#002 — 1MG/ML (1MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 29, 2020