Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019416
Company: OTSUKA ICU MEDCL
Company: OTSUKA ICU MEDCL
| 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 |
|---|---|---|---|---|---|---|---|
| 01/17/1986 | 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 |
|---|---|---|---|---|---|
| 08/15/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/11/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1986 | SUPPL-1 | Manufacturing (CMC) |
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 | OTSUKA ICU MEDCL |