Orange Book product · Generic (ANDA)
RAMELTEON
RAMELTEON
At a glance
Feb 09, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 09, 2023
3 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
RAMELTEON
Strength
8MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215243
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RAMELTEON
- 2005ROZEREMBrand (NDA)
NDA 021782 · TAKEDA PHARMS USA
- 2026RAMELTEONGeneric (ANDA)
ANDA 215485 · HIBROW HLTHCARE
- 2023RAMELTEONGeneric (ANDA)
ANDA 215972 · AUROBINDO PHARMA LTD
- 2022RAMELTEONGeneric (ANDA)
ANDA 216209 · XIROMED
- 2022RAMELTEONGeneric (ANDA)
ANDA 215435 · ANDAS 5 HOLDING
- 2020RAMELTEONGeneric (ANDA)
ANDA 213815 · APPCO
- 2020RAMELTEONGeneric (ANDA)
ANDA 213186 · GRANULES
- 2020RAMELTEONGeneric (ANDA)
ANDA 212650 · I3 PHARMS
- 2019RAMELTEONGeneric (ANDA)
ANDA 211567 · ZYDUS PHARMS
- 2015RAMELTEONGeneric (ANDA)
ANDA 091610 · ACTAVIS LABS FL INC
- 2013RAMELTEONGeneric (ANDA)
ANDA 091693 · DR REDDYS LABS SA
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.
