Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019024
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHYSIOLYTE IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION;IRRIGATION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/08/1984 | 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 |
|---|---|---|---|---|---|
| 05/08/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/2003 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19024slr015ltr.pdf |
| 07/08/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/1990 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/19/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |