Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212650
Company: I3 PHARMS
Company: I3 PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/10/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/05/2022 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
RAMELTEON
TABLET;ORAL; 8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 091610 | ACTAVIS LABS FL INC |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 215435 | ANDAS 5 HOLDING |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 215972 | AUROBINDO PHARMA LTD |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 091693 | DR REDDYS LABS SA |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 213186 | GRANULES |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 212650 | I3 PHARMS |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 215243 | MICRO LABS |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 213815 | UPSHER SMITH LABS |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 216209 | XIROMED |
RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 211567 | ZYDUS PHARMS |
ROZEREM | RAMELTEON | 8MG | TABLET;ORAL | Prescription | Yes | AB | 021782 | TAKEDA PHARMS USA |