Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019870
Company: B BRAUN
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE | 5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML | INJECTABLE;INJECTION | Discontinued | 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 |
---|---|---|---|---|---|---|---|
06/10/1993 | 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 |
---|---|---|---|---|---|
05/11/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/01/2002 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/15/2002 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/07/2000 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/15/2000 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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08/21/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/13/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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06/01/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |