Details for New Drug Application (NDA): 205331
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NDA 205331 describes ADENOSINE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma, Mylan Labs Ltd, Pharmobedient, Rising, Teva Pharms Usa, Wockhardt, Avet Lifesciences, Eugia Pharma, Hospira, Meitheal, and Mylan Asi, and is included in twenty-one NDAs. It is available from thirteen suppliers. Additional details are available on the ADENOSINE profile page.
The generic ingredient in ADENOSINE is adenosine. There are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adenosine profile page.
The generic ingredient in ADENOSINE is adenosine. There are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adenosine profile page.
Summary for 205331
| Tradename: | ADENOSINE |
| Applicant: | Eugia Pharma |
| Ingredient: | adenosine |
| Patents: | 0 |
Pharmacology for NDA: 205331
| Mechanism of Action | Adenosine Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 205331
Suppliers and Packaging for NDA: 205331
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | adenosine | SOLUTION;INTRAVENOUS | 205331 | ANDA | Eugia US LLC | 55150-192 | 55150-192-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-192-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
| ADENOSINE | adenosine | SOLUTION;INTRAVENOUS | 205331 | ANDA | Eugia US LLC | 55150-192 | 55150-192-20 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-192-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 60MG/20ML (3MG/ML) | ||||
| Approval Date: | Nov 2, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 90MG/30ML (3MG/ML) | ||||
| Approval Date: | Nov 2, 2017 | TE: | AP | RLD: | No | ||||
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