Orange Book product · Brand (NDA)
ACCUTANE
ISOTRETINOIN
At a glance
May 07, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 07, 1982
44 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ISOTRETINOIN
Strength
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018662
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019ABSORICA LDBrand (NDA)
NDA 211913 · SUN PHARM
- 2012ABSORICABrand (NDA)
NDA 021951 · SUN PHARM INDS INC
- 2025ISOTRETINOINGeneric (ANDA)
ANDA 216097 · AMNEAL PHARMS NY
- 2025ISOTRETINOINGeneric (ANDA)
ANDA 216633 · ZYDUS PHARMS
- 2024ISOTRETINOINGeneric (ANDA)
ANDA 218194 · AUROBINDO PHARMA
- 2023ISOTRETINOINGeneric (ANDA)
ANDA 211568 · ZYDUS PHARMS
- 2021ISOTRETINOINGeneric (ANDA)
ANDA 212333 · UPSHER SMITH LABS
- 2021ISOTRETINOINGeneric (ANDA)
ANDA 213571 · UPSHER SMITH LABS
- 2021ISOTRETINOINGeneric (ANDA)
ANDA 205063 · ACTAVIS LABS FL
- 2017ISOTRETINOINGeneric (ANDA)
ANDA 207792 · AMNEAL PHARMS NY
- 2013ZENATANEGeneric (ANDA)
ANDA 202099 · DR REDDYS LABS LTD
- 2012MYORISANGeneric (ANDA)
ANDA 076485 · UPSHER SMITH LABS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
