Details for New Drug Application (NDA): 090212
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NDA 090212 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 is one drug master file entry 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adenosine profile page.
Pharmacology for NDA: 090212
| Mechanism of Action | Adenosine Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 090212
Suppliers and Packaging for NDA: 090212
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | adenosine | SOLUTION;INTRAVENOUS | 090212 | ANDA | Mylan Institutional LLC | 67457-856 | 67457-856-20 | 1 VIAL in 1 CARTON (67457-856-20) / 20 mL in 1 VIAL |
| ADENOSINE | adenosine | SOLUTION;INTRAVENOUS | 090212 | ANDA | Mylan Institutional LLC | 67457-857 | 67457-857-30 | 1 VIAL in 1 CARTON (67457-857-30) / 30 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 60MG/20ML (3MG/ML) | ||||
| Approval Date: | Mar 28, 2014 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 90MG/30ML (3MG/ML) | ||||
| Approval Date: | Mar 28, 2014 | TE: | AP | RLD: | No | ||||
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