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MIOCHOL

NDA

ACETYLCHOLINE CHLORIDE | N016211 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 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 Hyman Phelps & McNamara, P.C. FDA-2019-P-0372 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition on January 23, 2019, requesting that the FDA determine whether MIOCHOL (acetylcholine chloride) for intraocular solution, approved under NDA 016211 and held by Novartis Pharmaceuticals Corp., was withdrawn for reasons of safety or effectiven	505(q)	2019-01-25	Granted	Hyman Phelps & McNamara, P.C.

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs2 inactive

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

SIEGFRIED LTDInactiveACETYLCHOLINE CHLORIDE

DMF 60951985

SIGMA F AND D DIV LTDInactiveACETYLCHOLINE CHLORIDE

DMF 72211987

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

Products (1)

#001 — 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SOLUTION;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.