Details for New Drug Application (NDA): 078686
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NDA 078686 describes ADENOSINE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mylan Labs Ltd, 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 078686
| Tradename: | ADENOSINE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | adenosine |
| Patents: | 0 |
Pharmacology for NDA: 078686
| Mechanism of Action | Adenosine Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 078686
Suppliers and Packaging for NDA: 078686
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | adenosine | INJECTABLE;INJECTION | 078686 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1631 | 51662-1631-1 | 2 mL in 1 VIAL, SINGLE-DOSE (51662-1631-1) |
| ADENOSINE | adenosine | INJECTABLE;INJECTION | 078686 | ANDA | Mylan Institutional LLC | 67457-854 | 67457-854-04 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-854-04) / 4 mL in 1 VIAL, SINGLE-DOSE (67457-854-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3MG/ML | ||||
| Approval Date: | May 13, 2009 | TE: | AP | RLD: | No | ||||
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