Details for New Drug Application (NDA): 209666
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NDA 209666 describes MILRINONE LACTATE IN DEXTROSE 5%, which is a drug marketed by Eugia Pharma, Woodward, B Braun, Baxter Hlthcare, Gland Pharma Ltd, Hikma, Hospira, and West-ward Pharms Int, and is included in nine NDAs. It is available from one supplier. Additional details are available on the MILRINONE LACTATE IN DEXTROSE 5% profile page.
The generic ingredient in MILRINONE LACTATE IN DEXTROSE 5% is milrinone lactate. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.
The generic ingredient in MILRINONE LACTATE IN DEXTROSE 5% is milrinone lactate. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.
Summary for 209666
| Tradename: | MILRINONE LACTATE IN DEXTROSE 5% |
| Applicant: | Eugia Pharma |
| Ingredient: | milrinone lactate |
| Patents: | 0 |
Pharmacology for NDA: 209666
| Mechanism of Action | Phosphodiesterase 3 Inhibitors |
Medical Subject Heading (MeSH) Categories for 209666
Suppliers and Packaging for NDA: 209666
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MILRINONE LACTATE IN DEXTROSE 5% | milrinone lactate | INJECTABLE;INJECTION | 209666 | ANDA | Eugia US LLC | 55150-287 | 55150-287-10 | 10 POUCH in 1 CARTON (55150-287-10) / 1 BAG in 1 POUCH (55150-287-01) / 100 mL in 1 BAG |
| MILRINONE LACTATE IN DEXTROSE 5% | milrinone lactate | INJECTABLE;INJECTION | 209666 | ANDA | Eugia US LLC | 55150-288 | 55150-288-10 | 10 POUCH in 1 CARTON (55150-288-10) / 1 BAG in 1 POUCH (55150-288-01) / 200 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | ||||
| Approval Date: | Sep 3, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) | ||||
| Approval Date: | Sep 3, 2020 | TE: | AP | RLD: | No | ||||
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