Details for New Drug Application (NDA): 018044
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NDA 018044 describes ROCALTROL, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the ROCALTROL profile page.
The generic ingredient in ROCALTROL is calcitriol. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
The generic ingredient in ROCALTROL is calcitriol. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 018044
| Tradename: | ROCALTROL |
| Applicant: | Validus Pharms |
| Ingredient: | calcitriol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 018044
Suppliers and Packaging for NDA: 018044
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROCALTROL | calcitriol | CAPSULE;ORAL | 018044 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-138 | 43353-138-09 | 9000 CAPSULE in 1 BOTTLE (43353-138-09) |
| ROCALTROL | calcitriol | CAPSULE;ORAL | 018044 | NDA AUTHORIZED GENERIC | Aphena Pharma Solutions - Tennessee, LLC | 43353-138 | 43353-138-30 | 30 CAPSULE in 1 BOTTLE (43353-138-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MCG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 018044
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