Details for New Drug Application (NDA): 213717
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The generic ingredient in DOXERCALCIFEROL is doxercalciferol. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.
Summary for 213717
Tradename: | DOXERCALCIFEROL |
Applicant: | Eugia Pharma |
Ingredient: | doxercalciferol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213717
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 213717 | ANDA | Eugia US LLC | 55150-357 | 55150-357-50 | 50 CARTON in 1 CARTON (55150-357-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-357-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 213717 | ANDA | Eugia US LLC | 55150-358 | 55150-358-50 | 50 CARTON in 1 CARTON (55150-358-50) / 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-358-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MCG/ML (2MCG/ML) | ||||
Approval Date: | Jan 24, 2022 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4MCG/2ML (2MCG/ML) | ||||
Approval Date: | Jan 24, 2022 | TE: | AP | RLD: | No |
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