Request that the Commissioner of the Food and Drug Administration declare that the drug product, Escitalopram Oxalate Tablets, 15 mg, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4103

Request that the Commissioner of the Food and Drug Administration declare that the drug product, Escitalopram Oxalate Tablets, 15 mg, is suitable for submission as an ANDA

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensApr 15, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Lachman Consulting Services, Inc.	May 6, 2026	--

Keywords

CDER

Suitability Petition

Lachman Consulting Services, Inc.

declare that the drug product

Escitalopram Oxalate Tablets, 15 mg, is

suitable for submission as an ANDA

OPEN

Data from Regulations.gov