Details for New Drug Application (NDA): 020458
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NDA 020458 describes GALZIN, which is a drug marketed by Eton and is included in one NDA. It is available from two suppliers. Additional details are available on the GALZIN profile page.
The generic ingredient in GALZIN is zinc acetate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the zinc acetate profile page.
The generic ingredient in GALZIN is zinc acetate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the zinc acetate profile page.
Summary for 020458
| Tradename: | GALZIN |
| Applicant: | Eton |
| Ingredient: | zinc acetate |
| Patents: | 0 |
Pharmacology for NDA: 020458
| Physiological Effect | Decreased Copper Ion Absorption |
Suppliers and Packaging for NDA: 020458
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALZIN | zinc acetate | CAPSULE;ORAL | 020458 | NDA | Teva Pharmaceuticals USA, Inc. | 57844-208 | 57844-208-52 | 250 CAPSULE in 1 BOTTLE (57844-208-52) |
| GALZIN | zinc acetate | CAPSULE;ORAL | 020458 | NDA | Teva Pharmaceuticals USA, Inc. | 57844-215 | 57844-215-52 | 250 CAPSULE in 1 BOTTLE (57844-215-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG ZINC | ||||
| Approval Date: | Jan 28, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG ZINC | ||||
| Approval Date: | Jan 28, 1997 | TE: | RLD: | Yes | |||||
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