Details for New Drug Application (NDA): 021751
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NDA 021751 describes PENTETATE ZINC TRISODIUM, which is a drug marketed by Hameln Pharma Plus and is included in one NDA. It is available from one supplier. Additional details are available on the PENTETATE ZINC TRISODIUM profile page.
The generic ingredient in PENTETATE ZINC TRISODIUM is pentetate zinc 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 zinc trisodium profile page.
The generic ingredient in PENTETATE ZINC TRISODIUM is pentetate zinc 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 zinc trisodium profile page.
Summary for 021751
| Tradename: | PENTETATE ZINC TRISODIUM |
| Applicant: | Hameln Pharma Plus |
| Ingredient: | pentetate zinc trisodium |
| Patents: | 0 |
Pharmacology for NDA: 021751
| Mechanism of Action | Lead Chelating Activity |
Suppliers and Packaging for NDA: 021751
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PENTETATE ZINC TRISODIUM | pentetate zinc trisodium | SOLUTION;INHALATION, INTRAVENOUS | 021751 | NDA | hameln pharma gmbh | 70651-002 | 70651-002-03 | 10 AMPULE in 1 PACKAGE (70651-002-03) / 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| Strength | EQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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