Details for New Drug Application (NDA): 212446
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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 212446
Tradename: | ICATIBANT ACETATE |
Applicant: | Cipla |
Ingredient: | icatibant acetate |
Patents: | 0 |
Pharmacology for NDA: 212446
Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Suppliers and Packaging for NDA: 212446
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212446 | ANDA | Cipla USA Inc. | 69097-664 | 69097-664-34 | 1 SYRINGE, GLASS in 1 CARTON (69097-664-34) / 3 mL in 1 SYRINGE, GLASS |
ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212446 | ANDA | Cipla USA Inc. | 69097-664 | 69097-664-68 | 3 SYRINGE, GLASS in 1 CARTON (69097-664-68) / 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: | Jul 13, 2020 | TE: | AP | RLD: | No |
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