Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
January 1960

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 January 23, 2020.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
01/04/1960 KENALOG-10
NDA #012041
ORIG-1 TRIAMCINOLONE ACETONIDE APOTHECON Type 3 - New Dosage Form Approval
01/06/1960 CARBOCAINE
NDA #012125
ORIG-1 MEPIVACAINE HYDROCHLORIDE EASTMAN KODAK Type 4 - New Combination Approval
01/06/1960 CARBOCAINE W/ NEO-COBEFRIN
NDA #012125
ORIG-1 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE EASTMAN KODAK Type 4 - New Combination Approval
01/13/1960 MEDIHALER ERGOTAMINE
NDA #012102
ORIG-1 ERGOTAMINE TARTRATE 3M Type 3 - New Dosage Form Approval
01/14/1960 DECLOMYCIN
NDA #050262
ORIG-1 DEMECLOCYCLINE HYDROCHLORIDE LEDERLE Approval
01/14/1960 ACHROMYCIN
NDA #050276
SUPPL-16 PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE LEDERLE Manufacturing (CMC) Approval
01/19/1960 ADDERALL 10
NDA #011522
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Type 2 New Active Ingredient and Type 4 New Combination Approval
01/19/1960 ADDERALL 12.5
NDA #011522
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Type 2 New Active Ingredient and Type 4 New Combination Approval
01/19/1960 ADDERALL 15
NDA #011522
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Type 2 New Active Ingredient and Type 4 New Combination Approval
01/19/1960 ADDERALL 20
NDA #011522
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Type 2 New Active Ingredient and Type 4 New Combination Approval
01/19/1960 ADDERALL 30
NDA #011522
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Type 2 New Active Ingredient and Type 4 New Combination Approval
01/19/1960 ADDERALL 5
NDA #011522
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Type 2 New Active Ingredient and Type 4 New Combination Approval
01/19/1960 ADDERALL 7.5
NDA #011522
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TEVA WOMENS Type 2 New Active Ingredient and Type 4 New Combination Approval
01/21/1960 ALDACTONE
NDA #012151
ORIG-1 SPIRONOLACTONE GD SEARLE LLC Type 1 - New Molecular Entity Approval

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