Details for New Drug Application (NDA): 205568
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NDA 205568 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.
Summary for 205568
| Tradename: | ADENOSINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | adenosine |
| Patents: | 0 |
Pharmacology for NDA: 205568
| Mechanism of Action | Adenosine Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 205568
Suppliers and Packaging for NDA: 205568
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ADENOSINE | adenosine | INJECTABLE;INJECTION | 205568 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1643 | 51662-1643-3 | 10 POUCH in 1 CASE (51662-1643-3) / 1 SYRINGE in 1 POUCH (51662-1643-2) / 2 mL in 1 SYRINGE (51662-1643-1) |
| ADENOSINE | adenosine | INJECTABLE;INJECTION | 205568 | 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3MG/ML | ||||
| Approval Date: | Apr 16, 2018 | TE: | AP | RLD: | No | ||||
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