Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018681
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | SOLUTION;IRRIGATION | Prescription | AT | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/27/1982 | 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 |
|---|---|---|---|---|---|
| 09/02/2014 | SUPPL-27 | Labeling-Container/Carton Labels |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf | |
| 05/31/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/16/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/18/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/02/2014 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018681s027lbl.pdf |
LACTATED RINGER'S IN PLASTIC CONTAINER
SOLUTION;IRRIGATION; 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 018681 | B BRAUN |
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018494 | BAXTER HLTHCARE |
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 018921 | BAXTER HLTHCARE |
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 019416 | OTSUKA ICU MEDCL |