Details for New Drug Application (NDA): 211021
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NDA 211021 describes ICATIBANT ACETATE, which is a drug marketed by Alembic, Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Teva Pharms Usa, and Wilshire Pharms Inc, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ICATIBANT ACETATE profile page.
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.
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 211021
| Tradename: | ICATIBANT ACETATE |
| Applicant: | Jiangsu Hansoh Pharm |
| Ingredient: | icatibant acetate |
| Patents: | 0 |
Pharmacology for NDA: 211021
| Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Suppliers and Packaging for NDA: 211021
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 211021 | ANDA | Hikma Pharmaceuticals USA Inc. | 24201-207 | 24201-207-01 | 1 SYRINGE, GLASS in 1 CARTON (24201-207-01) / 3 mL in 1 SYRINGE, GLASS |
| ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 211021 | ANDA | Hikma Pharmaceuticals USA Inc. | 24201-207 | 24201-207-03 | 3 CARTON in 1 CARTON (24201-207-03) / 1 SYRINGE, GLASS in 1 CARTON / 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: | Mar 9, 2020 | TE: | AP | RLD: | No | ||||
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