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Last Updated: June 22, 2021

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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 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 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
Pharmacology for NDA: 018044
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 Validus Pharmaceuticals LLC 30698-143 30698-143-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-01)
ROCALTROL calcitriol CAPSULE;ORAL 018044 NDA Validus Pharmaceuticals LLC 30698-143 30698-143-23 30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-23)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 018044

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-001 Approved Prior to Jan 1, 1982   Try Before You Buy   Try Before You Buy
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-002 Approved Prior to Jan 1, 1982   Try Before You Buy   Try Before You Buy
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-002 Approved Prior to Jan 1, 1982   Try Before You Buy   Try Before You Buy
Validus Pharms ROCALTROL calcitriol CAPSULE;ORAL 018044-001 Approved Prior to Jan 1, 1982   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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