Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
November 1988

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on September 25, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
11/01/1988 AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #019681
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
11/01/1988 AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019681
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
11/01/1988 AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019681
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
11/01/1988 AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #019681
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
11/01/1988 AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #019681
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
11/01/1988 AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #019681
AMINO ACIDS; DEXTROSE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
11/01/1988 AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019682
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC
11/01/1988 AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019682
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC
11/01/1988 AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019682
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC
11/07/1988 AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #019683
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC
11/07/1988 AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #019683
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC
11/07/1988 AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #019683
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC
11/07/1988 AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #019683
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC
11/22/1988 METROGEL
NDA #019737
METRONIDAZOLE Type 3 - New Dosage Form Priority GALDERMA LABS LP

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