Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215701
Company: SHANDONG
Company: SHANDONG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | 200MG/2ML(100MG/ML) | INJECTABLE;INJECTION | None (Tentative Approval) | None | No | No |
SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | 500MG/5ML(100MG/ML) | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
03/20/2023 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |