Details for New Drug Application (NDA): 080677
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The generic ingredient in MANNITOL 25% 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 080677
Tradename: | MANNITOL 25% |
Applicant: | Fresenius Kabi Usa |
Ingredient: | mannitol |
Patents: | 0 |
Pharmacology for NDA: 080677
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 080677
Suppliers and Packaging for NDA: 080677
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 080677 | ANDA | Fresenius Kabi USA, LLC | 63323-024 | 63323-024-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 12.5GM/50ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
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