Orange Book product · Generic (ANDA)
ISOTRETINOIN
ISOTRETINOIN
At a glance
Aug 29, 2023
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 29, 2023
2 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ISOTRETINOIN
Strength
10MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB1
Application
ANDA 211568
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ISOTRETINOIN
- 2019ABSORICA LDBrand (NDA)
NDA 211913 · SUN PHARM
- 2012ABSORICABrand (NDA)
NDA 021951 · SUN PHARM INDS INC
- 1982ACCUTANEBrand (NDA)
NDA 018662 · HOFFMANN LA ROCHE
- 2025ISOTRETINOINGeneric (ANDA)
ANDA 216097 · AMNEAL PHARMS NY
- 2025ISOTRETINOINGeneric (ANDA)
ANDA 216633 · ZYDUS PHARMS
- 2024ISOTRETINOINGeneric (ANDA)
ANDA 218194 · AUROBINDO PHARMA
- 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.
