Details for New Drug Application (NDA): 021068
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NDA 021068 describes ROCALTROL, which is a drug marketed by Esjay Pharma and is included in two NDAs. It is available from three 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. Twenty-four 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. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 021068
| Tradename: | ROCALTROL |
| Applicant: | Esjay Pharma |
| Ingredient: | calcitriol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021068
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROCALTROL | calcitriol | SOLUTION;ORAL | 021068 | NDA | Validus Pharmaceuticals LLC | 30698-911 | 30698-911-15 | 15 mL in 1 BOTTLE (30698-911-15) |
| ROCALTROL | calcitriol | SOLUTION;ORAL | 021068 | NDA AUTHORIZED GENERIC | Sun Pharmaceutical Industries, Inc. | 63304-241 | 63304-241-59 | 15 mL in 1 BOTTLE (63304-241-59) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MCG/ML | ||||
| Approval Date: | Nov 20, 1998 | TE: | AA | RLD: | Yes | ||||
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