Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 218814
Company: STERISCIENCE
Company: STERISCIENCE
| 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 |
|---|---|---|---|---|---|---|---|
| 07/28/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
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 |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214279 | B BRAUN MEDICAL |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214236 | DR REDDYS |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 219448 | FRESENIUS KABI USA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214364 | GLAND |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218727 | HIKMA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218728 | HIKMA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214338 | LUPIN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214230 | MANKIND PHARMA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214368 | MSN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213915 | MYLAN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215575 | QILU PHARM HAINAN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214311 | SANDOZ |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218814 | STERISCIENCE |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214319 | SUN PHARM INDS INC |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215260 | TAMARANG |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214126 | TEVA PHARMS USA INC |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214306 | ZENARA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214290 | ZYDUS PHARMS |
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 |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214236 | DR REDDYS |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214364 | GLAND |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218728 | HIKMA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214338 | LUPIN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214230 | MANKIND PHARMA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214368 | MSN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213915 | MYLAN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215575 | QILU PHARM HAINAN |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214311 | SANDOZ |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 218814 | STERISCIENCE |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214319 | SUN PHARM INDS INC |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 215260 | TAMARANG |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214126 | TEVA PHARMS USA INC |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214306 | ZENARA |
| SUGAMMADEX SODIUM | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214290 | ZYDUS PHARMS |