Requests that the FDA assign a Therapeutic Equivalance Evaluation Code ("TE Code") for the company's Vancomycin Injection, 500 mg/100 mL and 1 g/200 mL | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2019-P-1560

Requests that the FDA assign a Therapeutic Equivalance Evaluation Code ("TE Code") for the company's Vancomycin Injection, 500 mg/100 mL and 1 g/200 mL

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensApr 3, 2019

Documents

Type	Title	Posted	Comments	Status
Other	Memorandum from FDA CDER to FDA DMB	Mar 3, 2026	--

Keywords

CDER

Citizen Petition

Therapeutic Equivalance Evaluation Code

Vancomycin Injection

500mg/100 mL

1 g/200 mL

Xellia Pharmaceutical ApS

Xellia Pharmaceutical USA, LLC.

Hyman, Phelps & McNamara, P.C.

Data from Regulations.gov