Requests that the FDA to allow us to add the 100 mL bottle in ANDA 214382, according to the FDA guidance document "Determining Whether to Submit an ANDA or a 505(b) (2) Application", effective May 2019. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-3840

Requests that the FDA to allow us to add the 100 mL bottle in ANDA 214382, according to the FDA guidance document "Determining Whether to Submit an ANDA or a 505(b) (2) Application", effective May 2019.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensApr 10, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter form FDA CDER to Emprise Pharma LLC	Jul 6, 2026	--

Keywords

CDER

Suitability Petition

Emprise Pharma LLC

Shandong New Time Pharmaceutical Co Ltd

to allow us to

add the 100 mL bottle in ANDA 214382

according to the FDA guidance document

Determining Whether to Submit an ANDA

Data from Regulations.gov