Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207409
Company: ALEMBIC PHARMS LTD
Company: ALEMBIC PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ILOPERIDONE | ILOPERIDONE | 1MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ILOPERIDONE | ILOPERIDONE | 2MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ILOPERIDONE | ILOPERIDONE | 4MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ILOPERIDONE | ILOPERIDONE | 6MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ILOPERIDONE | ILOPERIDONE | 8MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
ILOPERIDONE | ILOPERIDONE | 10MG | TABLET;ORAL | None (Tentative Approval) | None | 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 |
---|---|---|---|---|---|---|---|
07/02/2018 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207409Orig1s000TAltr.pdf |