Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019022
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 3GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 5GM/100ML | INJECTABLE;INJECTION | Prescription | AP | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 11/01/1983 | 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 |
|---|---|---|---|---|---|
| 09/14/2018 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019022s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019022Orig1s031ltr.pdf | |
| 06/06/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016677Orig1s148,018016Orig1s062,019022Orig1s026ltr.pdf | |
| 08/26/2005 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf | |
| 06/09/2005 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019022s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019022s021ltr.pdf | |
| 08/14/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16677s124ltr.pdf |
| 04/29/1997 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/1985 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/26/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/14/2018 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019022s031lbl.pdf | |
| 12/22/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019022s026lbl.pdf | |
| 08/26/2005 | SUPPL-22 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf | |
| 06/09/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019022s021lbl.pdf |
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 |