Drugs@FDA: FDA-Approved Drugs
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. |
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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. |
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12/07/2000 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/15/2000 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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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. |
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07/21/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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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. |