Orange Book product · Generic (ANDA)
MIRABEGRON
MIRABEGRON
At a glance
Jun 30, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 30, 2025
1 yr ago
Today
Pharmaceutical detail
Active ingredient
MIRABEGRON
Strength
25MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 217989
Product number
001
Marketing status
RX
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 217061 · SAWAI USA
- 2025MIRABEGRONGeneric (ANDA)
ANDA 209434 · APOTEX
- 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.
