Pemetrexed Disodium

ANDA 207352, held by Nang Kuang Pharm Co. Pemetrexed Disodium.

As of Nov 15, 2026, ANDA 207352 (Pemetrexed Disodium), held by Nang Kuang Pharm Co, was first approved by FDA on May 25, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: May 25, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 25, 2022	Original application	Approved	None posted

Products

2 strengths and forms


Pemetrexed DisodiumEQ 100MG BASE/VIAL · powder;intravenous	Pemetrexed Disodium	Discontinued
Pemetrexed DisodiumEQ 500MG BASE/VIAL · powder;intravenous	Pemetrexed Disodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 6, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Mar 6, 2024	Supplement 5Labeling · Standard review	Approved	None posted
May 25, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 207352
Drugs@FDA: Overview at FDA
Company: Nang Kuang Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters