Orange Book product · Generic (ANDA)
MIRABEGRON
MIRABEGRON
At a glance
Jan 02, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 02, 2025
1 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
MIRABEGRON
Strength
25MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 209434
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MIRABEGRON
- 2021MYRBETRIQ GRANULESBrand (NDA)
NDA 213801 · APGDI
- 2012MYRBETRIQBrand (NDA)
NDA 202611 · APGDI
- 2026MIRABEGRONGeneric (ANDA)
ANDA 219941 · DEVA HOLDING AS
- 2026MIRABEGRONGeneric (ANDA)
ANDA 219323 · ALKEM LABS LTD
- 2025MIRABEGRONGeneric (ANDA)
ANDA 218543 · MSN
- 2025MIRABEGRONGeneric (ANDA)
ANDA 217989 · QILU
- 2025MIRABEGRONGeneric (ANDA)
ANDA 217061 · SAWAI USA
- 2024MIRABEGRONGeneric (ANDA)
ANDA 215948 · ALKEM LABS LTD
- 2022MIRABEGRONGeneric (ANDA)
ANDA 209488 · ZYDUS PHARMS
- 2022MIRABEGRONGeneric (ANDA)
ANDA 209485 · LUPIN
- 2019MIRABEGRONGeneric (ANDA)
ANDA 209446 · SAWAI USA
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.
