Details for New Drug Application (NDA): 077897
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NDA 077897 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 077897
| Tradename: | ADENOSINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | adenosine |
| Patents: | 0 |
Pharmacology for NDA: 077897
| Mechanism of Action | Adenosine Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 077897
Suppliers and Packaging for NDA: 077897
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | adenosine | SOLUTION;INTRAVENOUS | 077897 | ANDA | Fresenius Kabi USA, LLC | 63323-651 | 63323-651-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-651-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
| ADENOSINE | adenosine | SOLUTION;INTRAVENOUS | 077897 | ANDA | Fresenius Kabi USA, LLC | 63323-651 | 63323-651-30 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-651-30) / 30 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 27, 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 27, 2017 | TE: | AP | RLD: | No | ||||
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