Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019632
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 | 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 |
|---|---|---|---|---|---|---|---|
| 02/29/1988 | 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 |
|---|---|---|---|---|---|
| 11/05/2025 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019632s067,019634s058,020002s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019632Orig1s067,019634Orig1s058,020002Orig1s037ltr.pdf | |
| 11/03/2021 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019632s050,019634s050,020002s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021019632Orig1s050, 019634Orig1s050, 020002Orig1s032ltr.pdf | |
| 06/17/2016 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/01/2002 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-17 | 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. |
||
| 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. |
||
| 11/22/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1988 | 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 |
|---|---|---|---|---|---|
| 11/05/2025 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019632s067,019634s058,020002s037lbl.pdf | |
| 11/03/2021 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019632s050,019634s050,020002s032lbl.pdf |
LACTATED RINGER'S IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
TE Code = AP
| 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 | INJECTABLE;INJECTION | Prescription | No | AP | 019632 | B BRAUN |
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016682 | BAXTER HLTHCARE |
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 209338 | FRESENIUS KABI USA |
| LACTATED RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 017641 | OTSUKA ICU MEDCL |