Details for New Drug Application (NDA): 212081
✉ Email this page to a colleague
NDA 212081 describes ICATIBANT ACETATE, which is a drug marketed by Cipla, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms Ltd, Jiangsu Hansoh Pharm, Nang Kuang Pharm Co, Slayback Pharma Llc, and Teva Pharms Usa, and is included in nine NDAs. It is available from nine 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the icatibant acetate profile page.
Summary for 212081
| Tradename: | ICATIBANT ACETATE |
| Applicant: | Nang Kuang Pharm Co |
| Ingredient: | icatibant acetate |
| Patents: | 0 |
Pharmacology for NDA: 212081
| Mechanism of Action | Bradykinin B2 Receptor Antagonists |
Suppliers and Packaging for NDA: 212081
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212081 | ANDA | Apotex Corp. | 60505-6214 | 60505-6214-1 | 1 SYRINGE, GLASS in 1 CARTON (60505-6214-1) / 3 mL in 1 SYRINGE, GLASS |
| ICATIBANT ACETATE | icatibant acetate | INJECTABLE;SUBCUTANEOUS | 212081 | ANDA | Bryant Ranch Prepack | 72162-2106 | 72162-2106-2 | 1 SYRINGE, GLASS in 1 CARTON (72162-2106-2) / 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: | Dec 16, 2020 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
