Orange Book product · Brand (NDA)
DALIRESP
ROFLUMILAST
At a glance
Jan 23, 2018
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 23, 2018
8 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ROFLUMILAST
Strength
250MCG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022522
Product number
002
Marketing status
RX
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.
- 2024ZORYVEBrand (NDA)
NDA 215985 · ARCUTIS
- 2023ZORYVEBrand (NDA)
NDA 217242 · ARCUTIS
- 2025ROFLUMILASTGeneric (ANDA)
ANDA 213298 · AUROBINDO PHARMA LTD
- 2024ROFLUMILASTGeneric (ANDA)
ANDA 208272 · TORRENT
- 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.
