Details for New Drug Application (NDA): 217074
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NDA 217074 describes ZINC SULFATE, which is a drug marketed by Abraxis Pharm, Am Regent, Apotex, Aspiro, Fresenius Kabi Usa, Gland, Nivagen Pharms Inc, Rk Pharma, Somerset Theraps Llc, and Zydus Pharms, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ZINC SULFATE profile page.
The generic ingredient in ZINC SULFATE is zinc sulfate. There are thirty-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zinc sulfate profile page.
The generic ingredient in ZINC SULFATE is zinc sulfate. There are thirty-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zinc sulfate profile page.
Summary for 217074
| Tradename: | ZINC SULFATE |
| Applicant: | Zydus Pharms |
| Ingredient: | zinc sulfate |
| Patents: | 0 |
Pharmacology for NDA: 217074
| Physiological Effect | Decreased Copper Ion Absorption |
Medical Subject Heading (MeSH) Categories for 217074
Suppliers and Packaging for NDA: 217074
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 217074 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1876 | 70710-1876-7 | 25 VIAL in 1 CARTON (70710-1876-7) / 10 mL in 1 VIAL (70710-1876-1) |
| ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 217074 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1877 | 70710-1877-7 | 25 VIAL in 1 CARTON (70710-1877-7) / 10 mL in 1 VIAL (70710-1877-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Aug 22, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | ||||
| Approval Date: | Aug 22, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 30MG BASE/10ML (EQ 3MG BASE/ML) | ||||
| Approval Date: | Aug 22, 2023 | TE: | AP | RLD: | No | ||||
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