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TETRACAINE HYDROCHLORIDE

NDA

TETRACAINE HYDROCHLORIDE | N210821 | BAUSCH AND LOMB IRELAND LTD

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 Chain9 active DMFs1 inactive

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

CHANGZHOU TIANHUA PHARMACEUTICAL CO LTDTETRACAINE HYDROCHLORIDE

DMF 224872008

CHANGZHOU TIANHUA PHARMACEUTICAL CO LTDTETRACAINE

DMF 224962008

CHIERON ACTIVE INGREDIENTS PRIVATE LTDTETRACAINE USP

DMF 241002010

SIEGFRIED EVIONNAZ SATETRACAINE HYDROCHLORIDE

DMF 320622017

CHIERON ACTIVE INGREDIENTS PRIVATE LTDTETRACAINE HYDROCHLORIDE

DMF 344622021

SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO LTDTETRACAINE

DMF 356152021

SIEGFRIED EVIONNAZ SATETRACAINE

DMF 373432025

STHREE CHEMICALS PRIVATE LTDTETRACAINE HYDROCHLORIDE

DMF 410982025

STHREE CHEMICALS PRIVATE LTDTETRACAINE USP

DMF 415802025

BEIJING JIKANLITONG PHARM TECH CO LTDInactiveTETRACAINE HYDROCHLORIDE

DMF 226092009

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 23, 2022	SUPPL -5	View Letter (PDF)
Mar 14, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

RLDAB1

0 patents0 exclusivities▴

SOLUTION;OPHTHALMIC | Approved: Mar 12, 2019

No patent or exclusivity listings for this strength.