Details for New Drug Application (NDA): 213585
✉ Email this page to a colleague
NDA 213585 describes MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Gland Pharma Ltd, Hikma, Hospira, West-ward Pharms Int, and Woodward, and is included in eight NDAs. It is available from four suppliers. Additional details are available on the MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER 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% IN PLASTIC CONTAINER 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 213585
| Tradename: | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | milrinone lactate |
| Patents: | 0 |
Pharmacology for NDA: 213585
| Mechanism of Action | Phosphodiesterase 3 Inhibitors |
Medical Subject Heading (MeSH) Categories for 213585
Suppliers and Packaging for NDA: 213585
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | milrinone lactate | INJECTABLE;INJECTION | 213585 | ANDA | Hospira, Inc. | 0409-1983 | 0409-1983-10 | 10 POUCH in 1 CARTON (0409-1983-10) / 1 BAG in 1 POUCH (0409-1983-01) / 200 mL in 1 BAG |
| MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | milrinone lactate | INJECTABLE;INJECTION | 213585 | ANDA | Hospira, Inc. | 0409-2045 | 0409-2045-10 | 10 POUCH in 1 CARTON (0409-2045-10) / 1 BAG in 1 POUCH (0409-2045-01) / 100 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: | Jul 16, 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: | Jul 16, 2020 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
