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 |
---|---|---|---|---|---|
11/03/2021 | SUPPL-32 | 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/2021/019632Orig1s050, 019634Orig1s050, 020002Orig1s032ltr.pdf | |
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. |
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04/15/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/07/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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08/21/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/03/2021 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019632s050,019634s050,020002s032lbl.pdf |
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 |