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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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Gland Pharma Limited FDA-2026-P-7043 · 4 docket documents Gland Pharma Limited filed a citizen petition requesting that the FDA withdraw its approval of the brand name Trecator-SC (ethionamide) tablets and take action against the current drug holder for failure to comply with manufacturing and marketing regulations. The petition urges the FDA to either rea	Other	2026-06-25	WithdrawnNo FDA response document on docket	Gland Pharma Limited

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

Clinical Trials

130 trials from ClinicalTrials.gov — 11 recruiting, 6 active, 87 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control NCT06667037	N/A	Active	Zhongshan Ophthalmic Center, Sun Yat-sen University	112	2024-09-21 → 2026-12-31
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
Myopia Control: a Comparison Study Between Atropine and MiSight NCT05815784	Phase 2	Active	Ann & Robert H Lurie Children's Hospital of Chicago	348	2023-05-02 → 2028-01-01
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
Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)NCT07756359	Phase 4	Not Yet Recruiting	University of North Carolina, Chapel Hill	20	2026-09 → 2027-09
Effectiveness of Digital Defocus Vision Training With Low-Concentration Atropine on the Prevention and Control of Myopia in Children: A Clinical Study NCT07724210	N/A	Not Yet Recruiting	Beijing Tongren Hospital	100	2026-08-20 → 2027-12-31
Magnesium Sulphate With Atropine and Pralidoxime vs Standard Therapy Alone in Acute Organophosphate Poisoning NCT07777835	N/A	Recruiting	Muhammad Aamir Latif	38	2026-05-10 → 2026-10-10
The Effect of Neostigmine and Sugammadex on the Optic Nerve Sheath Diameter NCT07666984	Phase 4	Recruiting	Cukurova University	86	2026-06-04 → 2026-07-10

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

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