Details for New Drug Application (NDA): 216435
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NDA 216435 describes EDETATE CALCIUM DISODIUM, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the EDETATE CALCIUM DISODIUM profile page.
The generic ingredient in EDETATE CALCIUM DISODIUM is edetate calcium disodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the edetate calcium disodium profile page.
The generic ingredient in EDETATE CALCIUM DISODIUM is edetate calcium disodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the edetate calcium disodium profile page.
Summary for 216435
| Tradename: | EDETATE CALCIUM DISODIUM |
| Applicant: | Casper Pharma Llc |
| Ingredient: | edetate calcium disodium |
| Patents: | 0 |
Pharmacology for NDA: 216435
| Mechanism of Action | Calcium Chelating Activity Lead Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 216435
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDETATE CALCIUM DISODIUM | edetate calcium disodium | INJECTABLE;INJECTION | 216435 | ANDA | Rising Pharma Holdings, Inc. | 64980-588 | 64980-588-51 | 5 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05) |
| EDETATE CALCIUM DISODIUM | edetate calcium disodium | INJECTABLE;INJECTION | 216435 | ANDA | Casper Pharma LLC | 70199-034 | 70199-034-55 | 5 VIAL in 1 CARTON (70199-034-55) / 5 mL in 1 VIAL (70199-034-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/ML | ||||
| Approval Date: | May 3, 2023 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Jan 8, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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