Viewing data from:

TETRACAINE HYDROCHLORIDE

ANDA

TETRACAINE HYDROCHLORIDE | A217227 | SOMERSET THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TETRACAINE HYDROCHLORIDE(TE code: AB1)

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

1 letter from Drugs@FDA

Date	Submission	Document
Feb 10, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

AB1

0 patents0 exclusivities▴

SOLUTION;OPHTHALMIC | Approved: Dec 20, 2024

No patent or exclusivity listings for this strength.