Icatibant is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Icatibant Acetate.
Product ID | 0093-3066_094ccc71-f1c2-49fa-a1d0-d01057107f8c |
NDC | 0093-3066 |
Product Type | Human Prescription Drug |
Proprietary Name | Icatibant |
Generic Name | Icatibant |
Dosage Form | Injection, Solution |
Route of Administration | SUBCUTANEOUS |
Marketing Start Date | 2019-07-15 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA210118 |
Labeler Name | Teva Pharmaceuticals USA, Inc. |
Substance Name | ICATIBANT ACETATE |
Active Ingredient Strength | 10 mg/mL |
Pharm Classes | Bradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2019-07-15 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA210118 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2019-07-15 |
Marketing Category | ANDA |
Application Number | ANDA210118 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2019-07-15 |
Marketing Category | ANDA |
Application Number | ANDA210118 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2019-07-15 |
Ingredient | Strength |
---|---|
ICATIBANT ACETATE | 10 mg/mL |
NDC | Brand Name | Generic Name |
---|---|---|
0093-3066 | Icatibant | Icatibant |
24201-207 | Icatibant | icatibant |
54092-135 | Icatibant | Icatibant |
60505-6214 | ICATIBANT | icatibant acetate |
63323-574 | Icatibant | Icatibant |
68462-828 | Icatibant | icatibant acetate |
69097-664 | ICATIBANT | ICATIBANT |
71225-114 | Icatibant | Icatibant |
70709-013 | SAJAZIR | ICATIBANT |