Details for New Drug Application (NDA): 013684
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NDA 013684 describes OSMITROL 5% IN WATER IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the OSMITROL 5% IN WATER IN PLASTIC CONTAINER profile page.
The generic ingredient in OSMITROL 5% IN WATER 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 OSMITROL 5% IN WATER 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 013684
| Tradename: | OSMITROL 5% IN WATER IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | mannitol |
| Patents: | 0 |
Pharmacology for NDA: 013684
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 013684
Suppliers and Packaging for NDA: 013684
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OSMITROL 10% IN WATER | mannitol | INJECTABLE;INJECTION | 013684 | NDA | Baxter Healthcare Company | 0338-0353 | 0338-0353-03 | 500 mL in 1 BAG (0338-0353-03) |
| OSMITROL 10% IN WATER IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 013684 | NDA | Baxter Healthcare Company | 0338-0353 | 0338-0353-03 | 500 mL in 1 BAG (0338-0353-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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