Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 211567
Company: ZYDUS PHARMS
Company: ZYDUS 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 |
|---|---|---|---|---|---|---|---|
| 07/22/2019 | ORIG-1 | Approval | STANDARD |
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 | 091693 | DR REDDYS LABS SA |
| RAMELTEON | RAMELTEON | 8MG | TABLET;ORAL | Prescription | No | AB | 211567 | ZYDUS PHARMS |
| ROZEREM | RAMELTEON | 8MG | TABLET;ORAL | Prescription | Yes | AB | 021782 | TAKEDA PHARMS USA |
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