Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019711
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOLYTE S IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1989 | 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 |
|---|---|---|---|---|---|
| 02/19/2004 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/01/2002 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 04/15/2002 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/2000 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/15/2000 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/12/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/21/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/13/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/04/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/12/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |