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Generated: April 25, 2019

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Details for New Drug Application (NDA): 021068

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NDA 021068 describes ROCALTROL, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from six 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-three suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 021068
Applicant:Validus Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 021068
Medical Subject Heading (MeSH) Categories for 021068
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:RXDosage:SOLUTION;ORALStrength1MCG/ML
Approval Date:Nov 20, 1998TE:AARLD:Yes

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