Details for New Drug Application (NDA): 216113
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NDA 216113 describes CUPRIC CHLORIDE, which is a drug marketed by Amneal, Exela Pharma, Somerset, Stira, and Hospira, and is included in five NDAs. It is available from six suppliers. Additional details are available on the CUPRIC CHLORIDE profile page.
The generic ingredient in CUPRIC CHLORIDE is cupric chloride. There is one drug master file entry for this compound. Seven 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. There is one drug master file entry for this compound. Seven 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 | ||||
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