Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076316
Company: HAEMONETICS
Company: HAEMONETICS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | 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 |
---|---|---|---|---|---|---|---|
10/27/2004 | ORIG-1 | Approval |
Label is not available on this site. |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 900MG/100ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 017464 | B BRAUN |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019635 | B BRAUN |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207310 | FRESENIUS KABI USA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 078177 | FRESENIUS MEDCL |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 076316 | HAEMONETICS |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019480 | HOSPIRA |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016366 | ICU MEDICAL INC |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 207956 | LABORATORIOS GRIFOLS |