Details for New Drug Application (NDA): 019603
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NDA 019603 describes MANNITOL 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Icu Medical Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the MANNITOL 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in MANNITOL 5% IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.
The generic ingredient in MANNITOL 5% IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.
Summary for 019603
| Tradename: | MANNITOL 5% IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | mannitol |
| Patents: | 0 |
Pharmacology for NDA: 019603
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 019603
Suppliers and Packaging for NDA: 019603
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MANNITOL 10% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 019603 | NDA | ICU Medical Inc. | 0990-7715 | 0990-7715-02 | 24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12) |
| MANNITOL 15% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 019603 | NDA | ICU Medical Inc. | 0990-7715 | 0990-7715-02 | 24 POUCH in 1 CASE (0990-7715-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG (0990-7715-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML | ||||
| Approval Date: | Jan 8, 1987 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10GM/100ML | ||||
| Approval Date: | Jan 8, 1987 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 15GM/100ML | ||||
| Approval Date: | Jan 8, 1990 | TE: | RLD: | No | |||||
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