Details for New Drug Application (NDA): 205360
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NDA 205360 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 eight 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the doxercalciferol profile page.
Summary for 205360
| Tradename: | DOXERCALCIFEROL |
| Applicant: | Avet |
| Ingredient: | doxercalciferol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205360
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXERCALCIFEROL | doxercalciferol | CAPSULE;ORAL | 205360 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-538 | 23155-538-25 | 50 CAPSULE in 1 BOTTLE (23155-538-25) |
| DOXERCALCIFEROL | doxercalciferol | CAPSULE;ORAL | 205360 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-539 | 23155-539-25 | 50 CAPSULE in 1 BOTTLE (23155-539-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
| Approval Date: | Sep 15, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MCG | ||||
| Approval Date: | Sep 15, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MCG | ||||
| Approval Date: | Sep 15, 2020 | TE: | AB | RLD: | No | ||||
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