Details for New Drug Application (NDA): 216113
✉ Email this page to a colleague
NDA 216113 describes CUPRIC CHLORIDE, which is a drug marketed by Exela Pharma, Rk Pharma, Somerset, and Hospira, and is included in four NDAs. It is available from four suppliers. Additional details are available on the CUPRIC CHLORIDE profile page.
The generic ingredient in CUPRIC CHLORIDE is cupric chloride. Five suppliers are listed for this compound. Additional details are available on the cupric chloride profile page.
The generic ingredient in CUPRIC CHLORIDE is cupric chloride. Five suppliers are listed for this compound. Additional details are available on the cupric chloride profile page.
Summary for 216113
| Tradename: | CUPRIC CHLORIDE |
| Applicant: | Somerset |
| Ingredient: | cupric chloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216113
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CUPRIC CHLORIDE | cupric chloride | INJECTABLE;INJECTION | 216113 | ANDA | Somerset Therapeutics, LLC | 70069-506 | 70069-506-25 | 25 VIAL, PLASTIC in 1 CARTON (70069-506-25) / 10 mL in 1 VIAL, PLASTIC (70069-506-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.4MG COPPER/ML | ||||
| Approval Date: | Apr 30, 2024 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Dec 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Complete Access Available with Subscription
