Tofacitinib Citrate

ANDA 212943, held by Ajanta Pharma Ltd. Tofacitinib Citrate.

As of Nov 15, 2026, ANDA 212943 (Tofacitinib Citrate), held by Ajanta Pharma Ltd, was first approved by FDA on Mar 20, 2026, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 20, 2026
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Mar 20, 2026	Original application	Approved	Letter
Jun 1, 2021	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tofacitinib CitrateEQ 10MG BASE · tablet;oral	Tofacitinib Citrate	Rx

All 7 submissions, including labeling and manufacturing supplements


Mar 20, 2026	Original application	Approved	Letter
Feb 18, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Feb 18, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Feb 18, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Feb 18, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Feb 18, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Jun 1, 2021	Original application	Approved	Letter

Identifiers

Application: ANDA 212943
Drugs@FDA: Overview at FDA
Company: Ajanta Pharma

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