Restasis, Restasis Multidose

NDA 50790, held by Abbvie. Cyclosporine.

As of Nov 13, 2026, NDA 50790 (Restasis, Restasis Multidose), held by Abbvie, was first approved by FDA on Dec 23, 2002, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2002
Review: Priority
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Cyclosporine ophthalmic emulsion, 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 23, 2002	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
Restasis0.05% · emulsion;ophthalmic	Cyclosporine	RxReference drug
Restasis Multidose0.05% · emulsion;ophthalmic	Cyclosporine	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 21, 2025	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 18, 2017	Supplement 27Labeling · Standard review	Approved	Letter Label
Oct 27, 2016	Supplement 24Manufacturing · Standard review	Approved	Review Label
Oct 27, 2016	Supplement 25Labeling · Standard review	Approved	Review Label
Jan 16, 2014	Supplement 22Manufacturing · Priority review	Approved	None posted
Dec 5, 2013	Supplement 23Manufacturing · Priority review	Approved	None posted
May 31, 2013	Supplement 21Manufacturing · Priority review	Approved	Label
Jan 16, 2013	Supplement 19Manufacturing · Priority review	Approved	None posted
Dec 3, 2012	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 27, 2007	Supplement 13Manufacturing	Approved	None posted
Oct 1, 2003	Supplement 3Manufacturing · Priority review	Approved	Letter
Oct 1, 2003	Supplement 4Labeling · Standard review	Approved	Letter
Sep 16, 2003	Supplement 1Labeling · Standard review	Approved	Label Letter
Sep 12, 2003	Supplement 2Manufacturing · Priority review	Approved	Review
Dec 23, 2002	Original applicationNew dosage form · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 50790
Drugs@FDA: Overview at FDA
Company: AbbVie

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