Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020002
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 33MG/100ML;30MG/100ML;860MG/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 |
|---|---|---|---|---|---|---|---|
| 04/17/1992 | 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 |
|---|---|---|---|---|---|
| 06/16/2004 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/01/2002 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
RINGER'S IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 33MG/100ML;30MG/100ML;860MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 33MG/100ML;30MG/100ML;860MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 020002 | B BRAUN |
| RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 33MG/100ML;30MG/100ML;860MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 016693 | BAXTER HLTHCARE |
| RINGER'S IN PLASTIC CONTAINER | CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE | 33MG/100ML;30MG/100ML;860MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018251 | ICU MEDICAL INC |
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