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SEVOFLURANE

ANDA

SEVOFLURANE | A214382 | SHANDONG NEW TIME PHARMACEUTICAL CO LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ULTANE(TE code: AN)

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Emprise Pharma LLC on behalf of Shandong New Time P... FDA-2026-P-3840 Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co., Ltd filed a suitability petition under section 505(j)(2)(C) of the FD&C Act requesting approval to add a 100 mL bottle presentation to the already approved ANDA 214382 for sevoflurane inhalation liquid, which is currently approved	Suitability	2026-04-10	Open	Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co.

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain6 active DMFs2 inactive

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

CENTRAL GLASS CO LTDSEVOFLURANE

DMF 111321994

SHANDONG NEW TIME PHARMACEUTICAL CO LTDSEVOFLURANE USP

DMF 227402009

JIANGSU HENGRUI PHARMACEUTICALS CO LTDSEVOFLURANE USP

DMF 305702016

BLUE-ZONE TECHNOLOGIES LTDSEVOFLURANE USP

DMF 388572023

HEBEI YIPIN PHARMACEUTICAL CO LTDSEVOFLURANE

DMF 421502025

SUPRIYA LIFESCIENCE LTDSEVOFLURANE USP

DMF 430482025

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveSEVOFLURANE (NON-STERILE BULK FORM)

DMF 190912005

JIANGSU HENGRUI MEDICINE CO LTDInactiveSEVOFLURANE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 249032011

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

Products (1)

#001 — 100%

0 patents0 exclusivities▴

LIQUID;INHALATION | Approved: Aug 18, 2023

No patent or exclusivity listings for this strength.