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ATROPEN

NDA

ATROPINE | N017106 | MERIDIAN MEDICAL TECHNOLOGIES LLC

4 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

4 petitions (3 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3 Draft of Atropine Prescribing Information re Suitability Petitio... FDA-2023-P-4550 Pharmobedient Consulting LLC filed a suitability petition regarding atropine prescribing information. The petition requests FDA guidance on the suitability of proposed labeling for an atropine product, as indicated by the draft prescribing information included as an attachment.	Suitability	2023-10-17	Open	Pharmobedient Consulting LLC
Attachment 4 Draft Guidance on Atropine Sulfate re Suitability Petition from ...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
Attachment 2 Atropine Prescribing Information re Suitability Petition from Ph... FDA-2023-P-4550 Pharmobedient Consulting LLC filed a suitability petition requesting that the FDA evaluate the prescribing information for atropine to determine its appropriateness and suitability for its intended use. The petition seeks FDA review of the product's labeling under regulatory mechanisms governing dru	Suitability	2023-10-17	Open	Pharmobedient Consulting LLC
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0004 Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Hydrocodone Bitartrate and Homatropine Methylbromide Syrup at a lower strength of 2.5 mg/0.75 mg per 5 mL suitable for submission as an abbreviated new drug application, with the reference lis	Other	2008-05-13	Granted	Lachman Consultant Services

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CURIA WISCONSIN INCATROPINE SULFATE, USP

DMF 284232014

ROLABO OUTSOURCING SLATROPINE USP

DMF 295212015

SIGMA F AND D DIV LTDInactiveATROPINE METHYL NITRATE AS SUPPLIED BY MAC FARALAN SMITH, LIMITED

DMF 55141983

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveATROPINE

DMF 57911985

BOEHRINGER INGELHEIM PHARMA KGInactiveATROPINE METHYLNITRATE

DMF 73341988

C-SQUARED PHARMA SARLInactiveATROPINE

DMF 357692021

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 25, 2020	SUPPL -52	View Letter (PDF)
Sep 21, 2004	SUPPL -32	View Letter (PDF)
Jun 25, 2003	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 2MG SULFATE/0.7ML

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 1MG SULFATE/0.7ML

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR | Approved: Jun 19, 2003

#003 — EQ 0.5MG SULFATE/0.7ML

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR | Approved: Jun 19, 2003

#004 — EQ 0.25MG SULFATE/0.3ML

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR | Approved: Sep 17, 2004