Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088912
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | Yes |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | Yes |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | Yes |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 18MG/2ML (9MG/ML) | SOLUTION;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/10/1985 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/11/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2007 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/13/2002 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/08/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/11/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/15/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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 |
SOLUTION;INJECTION; 270MG/30ML (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 | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088911 | FRESENIUS KABI USA |
| BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | Yes | AP | 018800 | HOSPIRA |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 088912 | FRESENIUS KABI USA |