Orange Book product · Generic (ANDA)
ROFLUMILAST
ROFLUMILAST
At a glance
Oct 18, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 18, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ROFLUMILAST
Strength
250MCG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 208272
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ROFLUMILAST
- 2024ZORYVEBrand (NDA)
NDA 215985 · ARCUTIS
- 2023ZORYVEBrand (NDA)
NDA 217242 · ARCUTIS
- 2018DALIRESPBrand (NDA)
NDA 022522 · ASTRAZENECA
- 2025ROFLUMILASTGeneric (ANDA)
ANDA 213298 · AUROBINDO PHARMA LTD
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208236 · SENORES PHARMS
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208247 · STRIDES PHARMA
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 212490 · ALKEM LABS LTD
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208213 · HETERO LABS LTD III
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208180 · MICRO LABS
- 2023ROFLUMILASTGeneric (ANDA)
ANDA 208303 · ZYDUS PHARMS
- 2022ROFLUMILASTGeneric (ANDA)
ANDA 208256 · MSN
- 2022ROFLUMILASTGeneric (ANDA)
ANDA 208299 · PRINSTON INC
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.
