Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
October 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 August 06, 2020.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
10/13/1988 POTASSIUM CITRATE
NDA #019647
POTASSIUM CITRATE Type 3 - New Dosage Form Standard UT SW MEDCTR
10/17/1988 POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/17/1988 POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/17/1988 POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/17/1988 POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/17/1988 POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/17/1988 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #019685
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/17/1988 POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019686
POTASSIUM CHLORIDE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/17/1988 POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019686
POTASSIUM CHLORIDE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard ICU MEDICAL INC
10/20/1988 POLYTRIM
NDA #050567
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE Type 4 - New Combination Standard ALLERGAN
10/21/1988 SANDOSTATIN
NDA #019667
OCTREOTIDE ACETATE Type 1 - New Molecular Entity Priority NOVARTIS
10/31/1988 ANSAID
NDA #018766
FLURBIPROFEN Type 3 - New Dosage Form Standard PHARMACIA AND UPJOHN

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