Claravis

Treats multiple inflammatory nodules with a diameter of 5 mm or greater. ANDA 76135, held by Teva Pharms USA. Isotretinoin.

As of Nov 15, 2026, ANDA 76135 (Claravis), held by Teva Pharms USA, was first approved by FDA on Apr 11, 2003, with 26 approved supplements and 0 published complete response letters.

First approved: Apr 11, 2003
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Claravis (isotretinoin capsules USP) is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, Claravis is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use: If a second course of Claravis treatment is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of treatment.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Apr 11, 2003	Original application	Approved	Other

Products

3 strengths and forms


Claravis40MG · capsule;oral	Isotretinoin	Rx
Claravis20MG · capsule;oral	Isotretinoin	Rx
Claravis30MG · capsule;oral	Isotretinoin	Rx

All 27 submissions, including labeling and manufacturing supplements


Oct 7, 2026	Supplement 70REMS	Approved	None posted
Aug 21, 2026	Supplement 69Labeling · Standard review	Approved	None posted
Feb 9, 2026	Supplement 62REMS	Approved	None posted
Mar 4, 2024	Supplement 56Labeling · Standard review	Approved	None posted
Mar 24, 2023	Supplement 60REMS	Approved	None posted
Oct 6, 2022	Supplement 58REMS	Approved	None posted
Aug 23, 2022	Supplement 55Labeling · Standard review	Approved	None posted
Nov 8, 2021	Supplement 53Labeling · Standard review	Approved	None posted
Oct 8, 2021	Supplement 52REMS	Approved	None posted
Dec 9, 2020	Supplement 50REMS	Approved	None posted
Aug 31, 2018	Supplement 43Labeling · Standard review	Approved	None posted
May 2, 2018	Supplement 41Labeling · Standard review	Approved	None posted
Apr 23, 2018	Supplement 42REMS	Approved	None posted
Jun 17, 2017	Supplement 38REMS	Approved	None posted
Jul 8, 2016	Supplement 37REMS	Approved	None posted
Feb 4, 2016	Supplement 36REMS	Approved	None posted
Sep 3, 2015	Supplement 35REMS	Approved	None posted
Jul 20, 2015	Supplement 30Labeling · Standard review	Approved	None posted
Apr 12, 2012	Supplement 29REMS	Approved	None posted
Oct 22, 2010	Supplement 18REMS	Approved	None posted
Mar 25, 2010	Supplement 17Labeling	Approved	None posted
Nov 2, 2007	Supplement 15Labeling	Approved	None posted
Feb 2, 2007	Supplement 14Labeling	Approved	None posted
Feb 2, 2007	Supplement 11Labeling	Approved	None posted
May 11, 2006	Supplement 5Labeling	Approved	None posted
Aug 12, 2005	Supplement 8Labeling	Approved	None posted
Apr 11, 2003	Original application	Approved	Other

Identifiers

Application: ANDA 76135
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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