Details for New Drug Application (NDA): 080704
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NDA 080704 describes VITAMIN D, which is a drug marketed by Bionpharma, Chartwell Molecular, Chase Chem, Everylife, Impax Labs, Vitarine, and West Ward, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the VITAMIN D profile page.
The generic ingredient in VITAMIN D is ergocalciferol. There are six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
The generic ingredient in VITAMIN D is ergocalciferol. There are six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
Summary for 080704
| Tradename: | VITAMIN D |
| Applicant: | Bionpharma |
| Ingredient: | ergocalciferol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 080704
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VITAMIN D | ergocalciferol | CAPSULE;ORAL | 080704 | ANDA | AvKARE | 42291-266 | 42291-266-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-266-01) |
| VITAMIN D | ergocalciferol | CAPSULE;ORAL | 080704 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-711 | 43063-711-12 | 12 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43063-711-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50,000 IU | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | No | ||||
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