Protopic

NDA 50777, held by Leo Pharma As. Tacrolimus.

As of Nov 13, 2026, NDA 50777 (Protopic), held by Leo Pharma As, was first approved by FDA on Dec 8, 2000, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 8, 2000
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 8, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Protopic0.03% · ointment;topical	Tacrolimus	RxReference drug
Protopic0.1% · ointment;topical	Tacrolimus	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Feb 25, 2019	Supplement 21Manufacturing	Approved	Label Medication Guide
Nov 4, 2011	Supplement 18Labeling	Approved	Label Letter
Dec 31, 2008	Supplement 14Manufacturing	Approved	Letter
Jan 19, 2006	Supplement 12Labeling · Standard review	Approved	Letter Label
Jul 14, 2005	Supplement 10Manufacturing · Standard review	Approved	Letter
Dec 23, 2003	Supplement 6Manufacturing · Standard review	Approved	Label Letter
Apr 18, 2003	Supplement 4Manufacturing · Standard review	Approved	Letter Label
Nov 22, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 13, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 26, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 8, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 50777
Drugs@FDA: Overview at FDA
Company: LEO 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