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MIOSTAT

NDA

CARBACHOL | N016968 | ALCON LABORATORIES 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 Chain4 active DMFs

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

SIEGFRIED LTDCARBACHOL

DMF 40381981

SERATEC SASCARBACHOL

DMF 347832020

SERATEC INDUSTRIES SARLCARBACHOL

DMF 355742021

VISUS THERAPEUTICS INCCARBACHOL DRUG SUBSTANCE

DMF 405262025

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.01%

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.