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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 seven 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-one suppliers are listed for this compound. Additional details are available on the calcitriol profile page.

Summary for NDA: 018044

Tradename:
ROCALTROL
Applicant:
Validus Pharms
Ingredient:
calcitriol
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 018044

Ingredient-typeCholecalciferol

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 KAISER FOUNDATION HOSPITALS 0179-0063 0179-0063-70 30 CAPSULE, GELATIN COATED in 1 BOX, UNIT-DOSE (0179-0063-70)
ROCALTROL
calcitriol
CAPSULE;ORAL 018044 NDA KAISER FOUNDATION HOSPITALS 0179-0069 0179-0069-70 30 CAPSULE, GELATIN COATED in 1 BOX, UNIT-DOSE (0179-0069-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

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

Expired Orange Book Patents for NDA: 018044

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-001Approved Prior to Jan 1, 19823,697,559► subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-002Approved Prior to Jan 1, 19823,697,559► subscribe
Validus Pharms
ROCALTROL
calcitriol
CAPSULE;ORAL018044-002Approved Prior to Jan 1, 19824,341,774► subscribe
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