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MIOCHOL-E

NDA

ACETYLCHOLINE CHLORIDE | N020213 | BAUSCH AND LOMB INC

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

No FDA citizen petitions matched from Regulations.gov

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 6, 2006	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG/VIAL

RLD

0 patents0 exclusivities▴

FOR SOLUTION;OPHTHALMIC | Approved: Sep 22, 1993

No patent or exclusivity listings for this strength.