Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211277
Company: XIROMED
Company: XIROMED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
10/29/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
SODIUM NITROPRUSSIDE
INJECTABLE;INJECTION; 25MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209493 | AMNEAL |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214971 | BE PHARMS |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211016 | CAPLIN |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210114 | DR REDDYS |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209352 | MICRO LABS |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210763 | MYLAN LABS LTD |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207499 | NEXUS |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209584 | NORVIUM BIOSCIENCE |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207426 | SAGENT PHARMS INC |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214199 | SLATE RUN PHARMA |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210882 | SOMERSET THERAPS LLC |
SODIUM NITROPRUSSIDE | SODIUM NITROPRUSSIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211277 | XIROMED |