Details for New Drug Application (NDA): 091101
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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 091101
Tradename: | DOXERCALCIFEROL |
Applicant: | Hikma |
Ingredient: | doxercalciferol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 091101
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 091101 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6154 | 0641-6154-25 | 25 AMPULE in 1 BOX (0641-6154-25) / 2 mL in 1 AMPULE (0641-6154-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4MCG/2ML (2MCG/ML) | ||||
Approval Date: | Aug 30, 2013 | TE: | AP | RLD: | No |
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