Viewing data from:

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 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FDA determine whether Atropine Sulfate Injection, 0.4 mg/mL (NDA #214652) held by Accord Healthcare Inc was voluntarily withdrawn from sale for reasons of safety or effectiveness, as required under 21 CFR 314.161 before an ANDA for	505(q)	2026-06-25	Open	Gland Pharma Limited

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs1 inactive

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

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