Details for New Drug Application (NDA): 016269
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NDA 016269 describes MANNITOL 5%, which is a drug marketed by B Braun, Hospira, and Icu Medical Inc, and is included in four NDAs. It is available from three suppliers. Additional details are available on the MANNITOL 5% profile page.
The generic ingredient in MANNITOL 5% 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% 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 016269
| Tradename: | MANNITOL 5% |
| Applicant: | Hospira |
| Ingredient: | mannitol |
| Patents: | 0 |
Pharmacology for NDA: 016269
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 016269
Suppliers and Packaging for NDA: 016269
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MANNITOL 10% | mannitol | INJECTABLE;INJECTION | 016269 | NDA | Henry Schein, Inc. | 0404-9905 | 0404-9905-50 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE |
| MANNITOL 15% | mannitol | INJECTABLE;INJECTION | 016269 | NDA | Henry Schein, Inc. | 0404-9905 | 0404-9905-50 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 15GM/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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