Details for New Drug Application (NDA): 210452
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NDA 210452 describes DOXERCALCIFEROL, which is a drug marketed by Avet, Hikma, Rising, Alembic, Amneal, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hospira, Lupin Ltd, Meitheal, Sandoz, and Sun Pharm, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the DOXERCALCIFEROL profile page.
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.
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 210452
| Tradename: | DOXERCALCIFEROL |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | doxercalciferol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210452
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 210452 | ANDA | Dr.Reddy's Laboratories Inc | 43598-850 | 43598-850-50 | 50 VIAL, MULTI-DOSE in 1 CARTON (43598-850-50) / 2 mL in 1 VIAL, MULTI-DOSE (43598-850-11) |
| DOXERCALCIFEROL | doxercalciferol | INJECTABLE;INJECTION | 210452 | ANDA | Gland Pharma Limited | 68083-300 | 68083-300-50 | 50 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 4MCG/2ML (2MCG/ML) | ||||
| Approval Date: | Sep 26, 2019 | TE: | AP | RLD: | No | ||||
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