Details for New Drug Application (NDA): 216152
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NDA 216152 describes ZINC CHLORIDE, which is a drug marketed by Exela Pharma, Rk Pharma, Somerset, and Hospira, and is included in four NDAs. It is available from two suppliers. Additional details are available on the ZINC CHLORIDE profile page.
The generic ingredient in ZINC CHLORIDE is zinc chloride. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zinc chloride profile page.
The generic ingredient in ZINC CHLORIDE is zinc chloride. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zinc chloride profile page.
Summary for 216152
| Tradename: | ZINC CHLORIDE |
| Applicant: | Somerset |
| Ingredient: | zinc chloride |
| Patents: | 0 |
Pharmacology for NDA: 216152
| Physiological Effect | Decreased Copper Ion Absorption |
Suppliers and Packaging for NDA: 216152
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZINC CHLORIDE | zinc chloride | INJECTABLE;INJECTION | 216152 | ANDA | Somerset Therapeutics, LLC | 70069-526 | 70069-526-25 | 25 VIAL, PLASTIC in 1 CARTON (70069-526-25) / 10 mL in 1 VIAL, PLASTIC (70069-526-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG ZINC/ML | ||||
| Approval Date: | Oct 16, 2024 | TE: | AP | RLD: | No | ||||
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