Orange Book product · Generic (ANDA)
RAMELTEON
RAMELTEON
At a glance
Aug 21, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 21, 2020
5 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
RAMELTEON
Strength
8MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 213186
Product number
001
Marketing status
DISCN
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
- 2023RAMELTEONGeneric (ANDA)
ANDA 215243 · MICRO LABS
- 2022RAMELTEONGeneric (ANDA)
ANDA 216209 · XIROMED
- 2022RAMELTEONGeneric (ANDA)
ANDA 215435 · ANDAS 5 HOLDING
- 2020RAMELTEONGeneric (ANDA)
ANDA 213815 · APPCO
- 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.
