Details for New Drug Application (NDA): 021749
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NDA 021749 describes PENTETATE CALCIUM TRISODIUM, which is a drug marketed by Hameln and is included in one NDA. It is available from one supplier. Additional details are available on the PENTETATE CALCIUM TRISODIUM profile page.
The generic ingredient in PENTETATE CALCIUM TRISODIUM is pentetate calcium trisodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pentetate calcium trisodium profile page.
The generic ingredient in PENTETATE CALCIUM TRISODIUM is pentetate calcium trisodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pentetate calcium trisodium profile page.
Summary for 021749
| Tradename: | PENTETATE CALCIUM TRISODIUM |
| Applicant: | Hameln |
| Ingredient: | pentetate calcium trisodium |
| Patents: | 0 |
Pharmacology for NDA: 021749
| Mechanism of Action | Lead Chelating Activity |
Suppliers and Packaging for NDA: 021749
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENTETATE CALCIUM TRISODIUM | pentetate calcium trisodium | SOLUTION;INHALATION, INTRAVENOUS | 021749 | NDA | hameln pharma gmbh | 70651-001 | 70651-001-03 | 10 AMPULE in 1 PACKAGE (70651-001-03) / 5 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION, INTRAVENOUS | Strength | EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Aug 11, 2004 | TE: | RLD: | Yes | |||||
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