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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
October 1995

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 April 23, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
10/04/1995 CASODEX
NDA #020498		 BICALUTAMIDE Type 1 - New Molecular Entity Standard ANI PHARMS
10/06/1995 ORUDIS KT
NDA #020429		 KETOPROFEN Type 3 - New Dosage Form Standard WYETH CONS
10/06/1995 ACTRON
NDA #020499		 KETOPROFEN Type 3 - New Dosage Form Standard BAYER
10/19/1995 ZITHROMAX
NDA #050710		 AZITHROMYCIN Type 3 - New Dosage Form Standard PFIZER
10/20/1995 ATROVENT
NDA #020393		 IPRATROPIUM BROMIDE Type 3 - New Dosage Form Standard BOEHRINGER INGELHEIM
10/20/1995 ATROVENT
NDA #020394		 IPRATROPIUM BROMIDE Type 3 - New Dosage Form Standard BOEHRINGER INGELHEIM
10/23/1995 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020147		 AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/23/1995 TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
NDA #020177		 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/24/1995 OMNIPAQUE 240
NDA #020608		 IOHEXOL Type 5 - New Formulation or New Manufacturer Standard GE HEALTHCARE
10/24/1995 OMNIPAQUE 300
NDA #020608		 IOHEXOL Type 5 - New Formulation or New Manufacturer Standard GE HEALTHCARE
10/24/1995 OMNIPAQUE 350
NDA #020608		 IOHEXOL Type 5 - New Formulation or New Manufacturer Standard GE HEALTHCARE
10/27/1995 TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
NDA #020173		 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
10/27/1995 TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
NDA #020173		 AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard BAXTER HLTHCARE
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