Details for New Drug Application (NDA): 090038
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NDA 090038 describes MILRINONE LACTATE IN PLASTIC CONTAINER, which is a drug marketed by Hikma Farmaceutica and is included in one NDA. It is available from one supplier. Additional details are available on the MILRINONE LACTATE IN PLASTIC CONTAINER profile page.
The generic ingredient in MILRINONE LACTATE 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 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 090038
| Tradename: | MILRINONE LACTATE IN PLASTIC CONTAINER |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | milrinone lactate |
| Patents: | 0 |
Pharmacology for NDA: 090038
| Mechanism of Action | Phosphodiesterase 3 Inhibitors |
Medical Subject Heading (MeSH) Categories for 090038
Suppliers and Packaging for NDA: 090038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MILRINONE LACTATE IN PLASTIC CONTAINER | milrinone lactate | INJECTABLE;INJECTION | 090038 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9718 | 0143-9718-10 | 10 CONTAINER in 1 PACKAGE (0143-9718-10) / 200 mL in 1 CONTAINER (0143-9718-01) |
| MILRINONE LACTATE IN PLASTIC CONTAINER | milrinone lactate | INJECTABLE;INJECTION | 090038 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9719 | 0143-9719-10 | 10 CONTAINER in 1 PACKAGE (0143-9719-10) / 100 mL in 1 CONTAINER (0143-9719-01) |
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: | Jan 21, 2010 | 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: | Jan 21, 2010 | TE: | AP | RLD: | No | ||||
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