Details for New Drug Application (NDA): 003444
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NDA 003444 describes DRISDOL, which is a drug marketed by Ss Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the DRISDOL profile page.
The generic ingredient in DRISDOL 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 DRISDOL 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 003444
| Tradename: | DRISDOL |
| Applicant: | Ss Pharma |
| Ingredient: | ergocalciferol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 003444
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRISDOL | ergocalciferol | CAPSULE;ORAL | 003444 | NDA | Validus Pharmaceuticals LLC | 30698-493 | 30698-493-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (30698-493-01) |
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: | Yes | ||||
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