Details for New Drug Application (NDA): 210801
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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 210801
Tradename: | DOXERCALCIFEROL |
Applicant: | Lupin Ltd |
Ingredient: | doxercalciferol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210801
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 210801 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-718 | 68180-718-52 | 50 VIAL, MULTI-DOSE in 1 CARTON (68180-718-52) / 2 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4MCG/2ML (2MCG/ML) | ||||
Approval Date: | Nov 1, 2018 | TE: | AP | RLD: | No |
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