NDC 0187-5400
JUBLIA
Efinaconazole
JUBLIA is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Valeant Pharmaceuticals North America Llc. The primary component is Efinaconazole.
| Product ID | 0187-5400_424ea0a1-aaad-43b3-b0be-f78c27e8858c |
| NDC | 0187-5400 |
| Product Type | Human Prescription Drug |
| Proprietary Name | JUBLIA |
| Generic Name | Efinaconazole |
| Dosage Form | Solution |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2014-06-06 |
| Marketing Category | NDA / NDA |
| Application Number | NDA203567 |
| Labeler Name | Valeant Pharmaceuticals North America LLC |
| Substance Name | EFINACONAZOLE |
| Active Ingredient Strength | 100 mg/mL |
| Pharm Classes | Azole Antifungal [EPC],Azoles [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0187-5400-02
1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) > 2 mL in 1 BOTTLE, WITH APPLICATOR
| Marketing Start Date | 2015-12-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0187-5400-08 [00187540008]
JUBLIA SOLUTION
| Marketing Category | NDA |
| Application Number | NDA203567 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-06 |
NDC 0187-5400-10 [00187540010]
JUBLIA SOLUTION
| Marketing Category | NDA |
| Application Number | NDA203567 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-06-06 |
| Marketing End Date | 2019-07-24 |
NDC 0187-5400-02 [00187540002]
JUBLIA SOLUTION
| Marketing Category | NDA |
| Application Number | NDA203567 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-12-17 |
NDC 0187-5400-04 [00187540004]
JUBLIA SOLUTION
| Marketing Category | NDA |
| Application Number | NDA203567 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-06 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| EFINACONAZOLE | 100 mg/mL |
OpenFDA Data
| SPL SET ID: | 922d4d25-c530-11e1-9b21-0800200c9a66 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Azole Antifungal [EPC]
- Azoles [CS]
Trademark Results [JUBLIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JUBLIA 86414520 4775839 Live/Registered |
BAUSCH HEALTH IRELAND LIMITED 2014-10-03 |
 JUBLIA 85261969 4359772 Live/Registered |
BAUSCH HEALTH IRELAND LIMITED 2011-03-09 |
 JUBLIA 78862951 not registered Dead/Abandoned |
Biovail Laboratories International SRL 2006-04-17 |
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