Absorica Ld

Treats multiple inflammatory nodules with a diameter of 5 mm or greater. NDA 211913, held by Sun Pharm. Isotretinoin.

As of Nov 15, 2026, NDA 211913 (Absorica Ld), held by Sun Pharm, was first approved by FDA on Nov 5, 2019, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 5, 2019
Review: Standard
Supplements approved: 10
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 11 submissions below

Date	Submission	Status	Documents
Nov 5, 2019	Original applicationTYPE 4/5 · Standard review	Approved	REMS Review Label Letter

Products

6 strengths and forms


Absorica Ld8MG · capsule;oral	Isotretinoin	RxReference drug
Absorica Ld16MG · capsule;oral	Isotretinoin	RxReference drug
Absorica Ld20MG · capsule;oral	Isotretinoin	DiscontinuedReference drug
Absorica Ld24MG · capsule;oral	Isotretinoin	RxReference drug
Absorica Ld28MG · capsule;oral	Isotretinoin	DiscontinuedReference drug
Absorica Ld32MG · capsule;oral	Isotretinoin	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Oct 7, 2026	Supplement 24REMS	Approved	Letter
Aug 11, 2026	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 12, 2026	Supplement 14Labeling · Standard review	Approved	Letter Label Medication Guide
Feb 9, 2026	Supplement 13REMS	Approved	Letter
Jul 18, 2023	Supplement 11Labeling · Standard review	Approved	Label Letter
Mar 24, 2023	Supplement 10REMS	Approved	Letter
Oct 6, 2022	Supplement 9REMS	Approved	Letter
Apr 7, 2022	Supplement 5Labeling · Standard review	Approved	Label Letter
Oct 8, 2021	Supplement 4REMS	Approved	Letter
Dec 9, 2020	Supplement 3REMS	Approved	Letter
Nov 5, 2019	Original applicationTYPE 4/5 · Standard review	Approved	REMS Review Label Letter

Identifiers

Application: NDA 211913
Drugs@FDA: Overview at FDA
Company: Sun 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