Details for New Drug Application (NDA): 214380
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NDA 214380 describes MILRINONE LACTATE, which is a drug marketed by Baxter Hlthcare Corp, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Intl Medicated, Meitheal, Mylan Institutional, Shandong, Eugia Pharma, Woodward, B Braun, Baxter Hlthcare, and West-ward Pharms Int, and is included in twenty-five NDAs. It is available from nine suppliers. Additional details are available on the MILRINONE LACTATE profile page.
The generic ingredient in MILRINONE LACTATE 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 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 214380
| Tradename: | MILRINONE LACTATE |
| Applicant: | Caplin |
| Ingredient: | milrinone lactate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214380
| Mechanism of Action | Phosphodiesterase 3 Inhibitors |
Medical Subject Heading (MeSH) Categories for 214380
Suppliers and Packaging for NDA: 214380
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MILRINONE LACTATE | milrinone lactate | INJECTABLE;INJECTION | 214380 | ANDA | Caplin Steriles Limited | 65145-120 | 65145-120-10 | 10 VIAL in 1 CARTON (65145-120-10) / 10 mL in 1 VIAL (65145-120-01) |
| MILRINONE LACTATE | milrinone lactate | INJECTABLE;INJECTION | 214380 | ANDA | Caplin Steriles Limited | 65145-121 | 65145-121-10 | 10 VIAL in 1 CARTON (65145-121-10) / 20 mL in 1 VIAL (65145-121-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Apr 16, 2021 | TE: | AP | RLD: | No | ||||
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