Diclofenac Potassium

ANDA 75470, held by Sun Pharm Industries. Diclofenac Potassium.

As of Nov 15, 2026, ANDA 75470 (Diclofenac Potassium), held by Sun Pharm Industries, was first approved by FDA on Feb 21, 2002, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 21, 2002
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 21, 2002	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diclofenac Potassium50MG · tablet;oral	Diclofenac Potassium	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Apr 30, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Oct 13, 2006	Supplement 10Labeling	Approved	None posted
Jul 28, 2006	Supplement 9Labeling	Approved	None posted
Feb 21, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75470
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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