Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214337
Company: ASPIRO
Company: ASPIRO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | No | No |
SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/09/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214337Orig1s000ltr.pdf |
SUGAMMADEX SODIUM
SOLUTION;INTRAVENOUS; EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRIDION | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022225 | MSD SUB MERCK |
SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214337 | ASPIRO |
SOLUTION;INTRAVENOUS; EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BRIDION | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 022225 | MSD SUB MERCK |
SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214337 | ASPIRO |