Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217535
Company: NEXUS PHARMS
Company: NEXUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | No |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;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 |
---|---|---|---|---|---|---|---|
08/23/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217535Orig1s000ltr.pdf |
SODIUM CHLORIDE 0.9%
SOLUTION;INJECTION; 90MG/10ML (9MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088911 | FRESENIUS KABI USA |
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018800 | HOSPIRA |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 201833 | HIKMA |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 217535 | NEXUS PHARMS |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 206171 | SPECTRA MDCL DEVICES |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088912 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018803 | HOSPIRA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 077407 | TARO |
SOLUTION;INJECTION; 180MG/20ML (9MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018800 | HOSPIRA |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 217535 | NEXUS PHARMS |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088912 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018803 | HOSPIRA |