Details for New Drug Application (NDA): 218059
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NDA 218059 describes ZINC SULFATE, which is a drug marketed by Abraxis Pharm, Am Regent, Apotex, Fresenius Kabi Usa, Gland Pharma Ltd, Nivagen Pharms Inc, Somerset Theraps Llc, and Zydus Pharms, and is included in eight NDAs. It is available from nine 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the zinc sulfate profile page.
Summary for 218059
| Tradename: | ZINC SULFATE |
| Applicant: | Apotex |
| Ingredient: | zinc sulfate |
| Patents: | 0 |
Pharmacology for NDA: 218059
| Physiological Effect | Decreased Copper Ion Absorption |
Medical Subject Heading (MeSH) Categories for 218059
Suppliers and Packaging for NDA: 218059
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZINC SULFATE | zinc sulfate | SOLUTION;INTRAVENOUS | 218059 | ANDA | Apotex Corp | 60505-6260 | 60505-6260-5 | 25 VIAL in 1 CARTON (60505-6260-5) / 5 mL in 1 VIAL (60505-6260-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 25MG BASE/5ML (EQ 5MG BASE/ML) | ||||
| Approval Date: | Jun 10, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 10MG BASE/10ML (EQ 1MG BASE/ML) | ||||
| Approval Date: | Oct 28, 2024 | TE: | AP | RLD: | No | ||||
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