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ATROPINE SULFATE

NDA

ATROPINE SULFATE | N021146 | HOSPIRA INC

3 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

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 4 Draft Guidance on Atropine Sulfate re Suitability Petition from ... FDA-2023-P-4550 Pharmobedient Consulting LLC filed a petition regarding atropine sulfate seeking FDA guidance on the suitability of the drug substance for use in pharmaceutical formulations. The petition requests clarification on regulatory pathways and acceptance criteria for atropine sulfate submissions under app	Suitability	2023-10-17	Open	Pharmobedient Consulting LLC
Second Amendment to ANDA Suitability Petition from Luitpold Pharmaceuticals Inc FDA-2012-P-0986 Luitpold Pharmaceuticals Inc. filed this second amendment to an ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting FDA approval to submit an ANDA for Atropine Sulfate Injection, USP at two new strengths: 1.0 mg/mL and 0.	Suitability	2018-03-08	Open	Luitpold Pharmaceuticals Inc

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

6 letters from Drugs@FDA

Date	Submission	Document
Aug 1, 2025	SUPPL -37	View Letter (PDF)
Jan 25, 2021	SUPPL -25	View Letter (PDF)
Jun 25, 2020	SUPPL -22	View Letter (PDF)
Jan 31, 2017	SUPPL -16	View Letter (PDF)
Nov 4, 2015	SUPPL -15	View Letter (PDF)
Jul 9, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 9, 2001

No patent or exclusivity listings for this strength.

#002 — 0.25MG/5ML (0.05MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 9, 2001

#003 — 1MG/10ML (0.1MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jul 9, 2001