Details for New Drug Application (NDA): 018316
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NDA 018316 describes SORBITOL-MANNITOL IN PLASTIC CONTAINER, which is a drug marketed by Hospira and Icu Medical Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the SORBITOL-MANNITOL IN PLASTIC CONTAINER profile page.
The generic ingredient in SORBITOL-MANNITOL IN PLASTIC CONTAINER is mannitol; sorbitol. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mannitol; sorbitol profile page.
The generic ingredient in SORBITOL-MANNITOL IN PLASTIC CONTAINER is mannitol; sorbitol. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mannitol; sorbitol profile page.
Summary for 018316
| Tradename: | SORBITOL-MANNITOL IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | mannitol; sorbitol |
| Patents: | 0 |
Pharmacology for NDA: 018316
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 018316
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SORBITOL-MANNITOL IN PLASTIC CONTAINER | mannitol; sorbitol | SOLUTION;IRRIGATION | 018316 | NDA | ICU Medical Inc. | 0990-7981 | 0990-7981-08 | 4 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IRRIGATION | Strength | 540MG/100ML;2.7GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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