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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
October 1982

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 February 28, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
10/01/1982 XENON XE 127
NDA #018536
XENON XE-127 Type 1 - New Molecular Entity Standard MALLINCKRODT
10/08/1982 DELSYM
NDA #018658
DEXTROMETHORPHAN POLISTIREX Type 3 - New Dosage Form Standard RB HLTH
10/14/1982 IOSAT
NDA #018664
POTASSIUM IODIDE ANBEX
10/22/1982 ZOVIRAX
NDA #018603
ACYCLOVIR SODIUM Type 2 - New Active Ingredient and Type 3 - New Dosage Form Priority GLAXOSMITHKLINE
10/22/1982 METRONIDAZOLE
NDA #018740
METRONIDAZOLE FOSUN PHARMA
10/27/1982 STERILE WATER FOR INJECTION
NDA #018801
STERILE WATER FOR INJECTION Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
10/27/1982 BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
NDA #018802
STERILE WATER FOR INJECTION Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
10/28/1982 HUMULIN R
BLA #018780
INSULIN HUMAN LILLY
10/28/1982 HUMULIN R
BLA #018780
INSULIN RECOMBINANT HUMAN LILLY
10/28/1982 HUMULIN R KWIKPEN
BLA #018780
INSULIN HUMAN LILLY
10/28/1982 HUMULIN R PEN
BLA #018780
INSULIN RECOMBINANT HUMAN LILLY
10/28/1982 HUMULIN N
BLA #018781
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY
10/29/1982 AMINOCAPROIC ACID
NDA #018590
AMINOCAPROIC ACID BAXTER HLTHCARE
10/29/1982 LOCOID
NDA #018652
HYDROCORTISONE BUTYRATE Type 3 - New Dosage Form Standard PRECISION DERMAT
10/29/1982 BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018800
SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
10/29/1982 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018803
SODIUM CHLORIDE Type 5 - New Formulation or New Manufacturer Standard HOSPIRA
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