Absorica

Treats multiple inflammatory nodules with a diameter of 5 mm or greater. NDA 21951, held by Sun Pharm Inds Inc. Isotretinoin.

As of Nov 14, 2026, NDA 21951 (Absorica), held by Sun Pharm Inds Inc, was first approved by FDA on May 25, 2012, with 24 approved supplements and 0 published complete response letters.

First approved: May 25, 2012
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ABSORICA and ABSORICA LD are 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, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use If a second course of ABSORICA/ABSORICA LD treatment is needed, it is not recommended before a 2-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of treatment. ABSORICA and

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
May 25, 2012	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Products

6 strengths and forms


Absorica10MG · capsule;oral	Isotretinoin	RxReference drug
Absorica20MG · capsule;oral	Isotretinoin	RxReference drug
Absorica30MG · capsule;oral	Isotretinoin	RxReference drug
Absorica40MG · capsule;oral	Isotretinoin	RxReference drug
Absorica25MG · capsule;oral	Isotretinoin	RxReference drug
Absorica35MG · capsule;oral	Isotretinoin	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Oct 7, 2026	Supplement 32REMS	Approved	Letter
Aug 11, 2026	Supplement 31Labeling · Standard review	Approved	Label Letter
Jun 12, 2026	Supplement 29Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 9, 2026	Supplement 28REMS	Approved	Letter
Jun 28, 2024	Supplement 16Labeling · Standard review	Approved	Label Letter
Jul 18, 2023	Supplement 24Labeling · Standard review	Approved	Label
Jul 18, 2023	Supplement 23Labeling · Standard review	Approved	Letter
Mar 24, 2023	Supplement 22REMS	Approved	Letter
Oct 6, 2022	Supplement 21REMS	Approved	Letter
Oct 8, 2021	Supplement 18REMS	Approved	Letter
Dec 9, 2020	Supplement 17REMS	Approved	Letter
Jan 24, 2020	Supplement 15REMS	Approved	Letter
Nov 7, 2019	Supplement 13Labeling · Standard review	Approved	Label Medication Guide Letter
Aug 31, 2018	Supplement 14Labeling · Standard review	Approved	Label Letter
May 2, 2018	Supplement 11Labeling · Standard review	Approved	Label Letter
Apr 23, 2018	Supplement 12REMS	Approved	Letter
Jun 17, 2017	Supplement 10REMS	Approved	Letter
Jul 8, 2016	Supplement 8REMS	Approved	Letter
Feb 4, 2016	Supplement 7REMS	Approved	Letter
Dec 23, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 3, 2015	Supplement 5REMS	Approved	Letter Label
Oct 20, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 15, 2014	Supplement 3Manufacturing · Standard review	Approved	Label Letter
Jul 30, 2014	Supplement 1Labeling	Approved	Letter Label
May 25, 2012	Original applicationNew dosage form · Standard review	Approved	Other Review Letter Label

Identifiers

Application: NDA 21951
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