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COGNEX

NDA

TACRINE HYDROCHLORIDE | N020070 | SHIONOGI INC

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

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.

DELMAR CHEMICALS INCInactiveTACRINE HYDROCHLORIDE MONOHYDRATE

DMF 71371987

NORDIC SYNTHESIS ABInactiveTACRINE HYDROCHLORIDE MONOHYDRATE

DMF 109621994

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 22, 2003	SUPPL -12	View Letter (PDF)
Jun 22, 2003	SUPPL -13	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 10MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 9, 1993

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 9, 1993

#003 — EQ 30MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 9, 1993

#004 — EQ 40MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Sep 9, 1993