Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019635
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION;INJECTION | Prescription | None | Yes | No |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 3GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 5GM/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 |
|---|---|---|---|---|---|---|---|
| 03/09/1988 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/26/2016 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/2015 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2015 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/2014 | SUPPL-35 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf | |
| 02/04/2004 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 02/04/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 06/13/2003 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/01/2002 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-16 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/08/2014 | SUPPL-35 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019635s035lbl.pdf |
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 450MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019635 | B BRAUN |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018016 | BAXTER HLTHCARE |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 208122 | FRESENIUS KABI USA |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019759 | HOSPIRA |
| SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018090 | ICU MEDICAL INC |
SODIUM CHLORIDE 0.9%
There are no Therapeutic Equivalents.
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 |
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 3GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 3GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019635 | B BRAUN |
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 3GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019022 | BAXTER HLTHCARE |
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 3GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 209476 | FRESENIUS KABI USA |
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 5GM/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019635 | B BRAUN |
| SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019022 | BAXTER HLTHCARE |