Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 020374
Company: FRESENIUS
Company: FRESENIUS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
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INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION;INTRAPERITONEAL | Discontinued | None | No | No |
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE | 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | SOLUTION;INTRAPERITONEAL | 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 |
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06/13/1994 | 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 |
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01/10/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/22/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/22/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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02/14/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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04/29/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/24/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/22/1997 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/24/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |