Orange Book product · Generic (ANDA)
ROFLUMILAST
ROFLUMILAST
At a glance
Jul 13, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 13, 2018
8 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ROFLUMILAST
Strength
500MCG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 208257
Product number
001
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
- 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
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.
