Details for New Drug Application (NDA): 018044

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NDA 018044 describes ROCALTROL, which is a drug marketed by Ss 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.

Summary for 018044

Tradename:	ROCALTROL
Applicant:	Ss Pharma
Ingredient:	calcitriol
Patents:	0

Pharmacology for NDA: 018044

Medical Subject Heading (MeSH) Categories for 018044

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

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:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MCG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018044

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ss Pharma	ROCALTROL	calcitriol	CAPSULE;ORAL	018044-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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