Orange Book product · Brand (NDA)

ABSORICA LD

ISOTRETINOIN

Brand (NDA)NDA 211913RX SUN PHARM

Nov 05, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 05, 2019
6 yr 9 mo ago
Today
Patent 9750711 expires
Listed drug product patent expiration.
May 29, 2035
in 9 yr 1 mo
Patent 9700535 expires
Listed drug product patent expiration.
Aug 04, 2035
in 9 yr 3 mo

Active ingredient

ISOTRETINOIN

Strength

16MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 211913

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9750711	May 29, 2035	in 9 yr 1 mo	Product
9700535	Aug 04, 2035	in 9 yr 3 mo	Product