Details for New Drug Application (NDA): 013684
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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 Corporation | 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 Corporation | 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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