Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019513
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS | 5GM/100ML;30MG/100ML;141MG/100ML;15MG/100ML;260MG/100ML;25MG/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 |
|---|---|---|---|---|---|---|---|
| 05/08/1986 | 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 |
|---|---|---|---|---|---|
| 09/05/2013 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 10/29/1998 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/22/1998 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/11/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/20/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/06/1996 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/04/1996 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/18/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/29/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/27/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/28/1992 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/10/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/11/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/13/1989 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/26/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/08/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |