Details for New Drug Application (NDA): 021068
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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: | Ss 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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