Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018494
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 02/19/1982 | 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 |
|---|---|---|---|---|---|
| 09/26/2014 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1993 | 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. |
||
| 01/10/1991 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/30/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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 | ICU MEDICAL INC |