Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206890
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ILOPERIDONE | ILOPERIDONE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
ILOPERIDONE | ILOPERIDONE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
ILOPERIDONE | ILOPERIDONE | 4MG | TABLET;ORAL | Discontinued | None | No | No |
ILOPERIDONE | ILOPERIDONE | 6MG | TABLET;ORAL | Discontinued | None | No | No |
ILOPERIDONE | ILOPERIDONE | 8MG | TABLET;ORAL | Discontinued | None | No | No |
ILOPERIDONE | ILOPERIDONE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
ILOPERIDONE | ILOPERIDONE | 12MG | TABLET;ORAL | Discontinued | 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 |
---|---|---|---|---|---|---|---|
05/05/2022 | ORIG-1 | Approval | STANDARD |
Review (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/206890Orig1s000.pdf |