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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
August 1955

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

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 26, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
08/02/1955 CYSTOGRAFIN
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 CYSTOGRAFIN DILUTE
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 DIATRIZOATE MEGLUMINE
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 RENO-30
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 RENO-60
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 RENO-DIP
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 RENOGRAFIN-60
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 RENOGRAFIN-76
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 RENOVIST
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/02/1955 RENOVIST II
NDA #010040		 ORIG-1 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM BRACCO Type 2 New Active Ingredient and Type 4 New Combination Approval
08/12/1955 SERPASIL
NDA #009115		 ORIG-1 RESERPINE NOVARTIS Type 2 - New Active Ingredient Approval
08/17/1955 CHLOROMYCETIN
NDA #050156		 SUPPL-5 CHLORAMPHENICOL PARKEDALE Manufacturing (CMC) Approval
08/18/1955 FLORINEF
NDA #010060		 ORIG-1 FLUDROCORTISONE ACETATE CASPER PHARMA LLC Type 3 - New Dosage Form Approval
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