Details for New Drug Application (NDA): 213773
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The generic ingredient in ICATIBANT ACETATE is icatibant acetate. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.
Summary for 213773
Tradename: | ICATIBANT ACETATE |
Applicant: | Alembic |
Ingredient: | icatibant acetate |
Patents: | 0 |
Pharmacology for NDA: 213773
Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Suppliers and Packaging for NDA: 213773
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213773 | ANDA | Alembic Pharmaceuticals Inc. | 62332-654 | 62332-654-03 | 1 SYRINGE, GLASS in 1 CARTON (62332-654-03) / 3 mL in 1 SYRINGE, GLASS |
ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 213773 | ANDA | Alembic Pharmaceuticals Inc. | 62332-654 | 62332-654-09 | 3 SYRINGE, GLASS in 1 CARTON (62332-654-09) / 3 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | EQ 30MG BASE/3ML (EQ 10MG BASE/ML) | ||||
Approval Date: | Jun 14, 2024 | TE: | AP | RLD: | No |
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