Details for New Drug Application (NDA): 207320
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NDA 207320 describes REGADENOSON, which is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Ge Healthcare, Gland Pharma Ltd, Hikma, Hospira, Ims Ltd, Indies Pharma, Meitheal, and Mylan, and is included in thirteen NDAs. It is available from thirteen suppliers. Additional details are available on the REGADENOSON profile page.
The generic ingredient in REGADENOSON is regadenoson. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.
The generic ingredient in REGADENOSON is regadenoson. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the regadenoson profile page.
Summary for 207320
| Tradename: | REGADENOSON |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | regadenoson |
| Patents: | 0 |
Pharmacology for NDA: 207320
| Mechanism of Action | Adenosine Receptor Agonists |
Suppliers and Packaging for NDA: 207320
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 207320 | ANDA | Gland Pharma Limited | 68083-175 | 68083-175-10 | 10 VIAL in 1 CARTON (68083-175-10) / 5 mL in 1 VIAL (68083-175-01) |
| REGADENOSON | regadenoson | SOLUTION;INTRAVENOUS | 207320 | ANDA | Almaject, Inc. | 72611-874 | 72611-874-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72611-874-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-874-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.4MG/5ML (0.08MG/ML) | ||||
| Approval Date: | Jul 12, 2022 | TE: | AP | RLD: | No | ||||
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