Drugs@FDA: FDA Approved Drug Products

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Original New Drug Application
NDA and BLA) Approvals
January 2018

This report lists all applications approved for the first time during the selected month. It includes New Molecular Entities (NMEs) and new biologics. * It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history.* Not all biologics are in Drugs@FDA.

This report was produced on October 15, 2019.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
01/09/2018 BALCOLTRA
NDA #208612
ETHINYL ESTRADIOL; LEVONORGESTREL Type 3 - New Dosage Form Standard AVION PHARMS
01/17/2018 CABAZITAXEL INJECTION
NDA #207970
CABAZITAXEL Type 5 - New Formulation or New Manufacturer Standard ACTAVIS LLC
01/18/2018 TIGECYCLINE
NDA #208744
TIGECYCLINE Type 5 - New Formulation or New Manufacturer Standard ACCORD HLTHCARE INC
01/25/2018 LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
NDA #205493
LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE Type 4 - New Combination Standard MICRO LABS LTD
01/26/2018 LUTATHERA
NDA #208700
LUTETIUM DOTATATE LU-177 Type 1 - New Molecular Entity Priority AAA USA INC
01/26/2018 FIRVANQ KIT
NDA #208910
VANCOMYCIN HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Priority RXMTM THERAPS LLC
01/26/2018 ATROPINE SULFATE
NDA #209260
ATROPINE SULFATE Standard FRESENIUS KABI USA
01/26/2018 KAPSPARGO SPRINKLE
NDA #210428
METOPROLOL SUCCINATE Type 3 - New Dosage Form Standard SPIL
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination
Meaning
Priority: Review designation assigned to applications for drugs that treat serious conditions and provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies
Standard: Review designation assigned to applications for drugs that do not meet the priority review designation criteria

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