Baxdela is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Melinta Therapeutics, Llc. The primary component is Delafloxacin Meglumine.
Product ID | 70842-101_1fbc1d58-acc9-496d-b4b1-898da783df93 |
NDC | 70842-101 |
Product Type | Human Prescription Drug |
Proprietary Name | Baxdela |
Generic Name | Delafloxacin Meglumine |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2017-06-19 |
Marketing Category | NDA / NDA |
Application Number | NDA208610 |
Labeler Name | Melinta Therapeutics, LLC |
Substance Name | DELAFLOXACIN MEGLUMINE |
Active Ingredient Strength | 450 mg/1 |
Pharm Classes | Fluoroquinolone Antibacterial [EPC],Fluoroquinolones [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2017-06-19 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208610 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-06-19 |
Marketing Category | NDA |
Application Number | NDA208610 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-06-19 |
Marketing Category | NDA |
Application Number | NDA208610 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2019-07-09 |
Ingredient | Strength |
---|---|
DELAFLOXACIN MEGLUMINE | 450 mg/1 |
SPL SET ID: | fb77637a-88d9-4aea-958f-e270030ce30d |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
70842-101 | Baxdela | delafloxacin meglumine |
70842-102 | Baxdela | delafloxacin meglumine |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BAXDELA 88058147 5725767 Live/Registered |
Melinta Subsidiary Corp. 2018-07-30 |
BAXDELA 86707152 5561401 Live/Registered |
MELINTA SUBSIDIARY CORP. 2015-07-28 |