Itraconazole is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Vensun Pharmaceuticals, Inc.. The primary component is Itraconazole.
Product ID | 42543-113_664190f4-1b7c-457b-855e-575ee2bedba5 |
NDC | 42543-113 |
Product Type | Human Prescription Drug |
Proprietary Name | Itraconazole |
Generic Name | Itraconazole |
Dosage Form | Capsule |
Route of Administration | ORAL |
Marketing Start Date | 2020-01-31 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA206410 |
Labeler Name | Vensun Pharmaceuticals, Inc. |
Substance Name | ITRACONAZOLE |
Active Ingredient Strength | 100 mg/1 |
Pharm Classes | Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2020-01-31 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA206410 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA206410 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2020-01-31 |
Marketing Category | ANDA |
Application Number | ANDA206410 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2020-01-31 |
Ingredient | Strength |
---|---|
ITRACONAZOLE | 100 mg/1 |
NDC | Brand Name | Generic Name |
---|---|---|
0378-5100 | Itraconazole | itraconazole |
10147-0150 | itraconazole | itraconazole |
10147-1700 | itraconazole | ITRACONAZOLE |
13668-463 | Itraconazole | Itraconazole |
16714-743 | Itraconazole | Itraconazole |
16729-271 | Itraconazole | ITRACONAZOLE |
31722-006 | Itraconazole | Itraconazole |
42543-113 | Itraconazole | Itraconazole |
46708-204 | ITRACONAZOLE | itraconazole |
49884-239 | Itraconazole | Itraconazole |
50268-450 | Itraconazole | Itraconazole |
67877-454 | Itraconazole | Itraconazole |
68151-2718 | itraconazole | itraconazole |
68382-697 | itraconazole | itraconazole |
70771-1208 | itraconazole | itraconazole |
59746-282 | itraconazole | itraconazole |
60687-299 | Itraconazole | Itraconazole |
62332-204 | ITRACONAZOLE | ITRACONAZOLE |
65162-630 | Itraconazole | Itraconazole |
65162-087 | Itraconazole | Itraconazole |
63629-8168 | Itraconazole | Itraconazole |
70518-2872 | Itraconazole | Itraconazole |
0259-1420 | Onmel | ITRACONAZOLE |
50458-290 | SPORANOX | ITRACONAZOLE |
50458-295 | SPORANOX | itraconazole |
51862-462 | Tolsura | Itraconazole |