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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091356

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NDA 091356 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma Inc, Strides Pharma, Teva, West-ward Pharms Int, Akorn, Fresenius Kabi Usa, Fresenius Medcl, Hospira, Luitpold, Rockwell Medcl, Sagent Pharms, and Teva Parenteral, and is included in fourteen NDAs. It is available from fourteen suppliers. Additional details are available on the CALCITRIOL profile page.

The generic ingredient in CALCITRIOL 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 091356

Tradename:	CALCITRIOL
Applicant:	Strides Pharma
Ingredient:	calcitriol
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 091356

Ingredient-type	Cholecalciferol

Medical Subject Heading (MeSH) Categories for 091356

Bone Density Conservation Agents
Calcium Channel Agonists
Vitamins

Suppliers and Packaging for NDA: 091356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITRIOL	calcitriol	CAPSULE;ORAL	091356	ANDA	Atlantic Biologicals Corps	17856-0723	N	17856-0723-1
CALCITRIOL	calcitriol	CAPSULE;ORAL	091356	ANDA	Bryant Ranch Prepack	63629-7311	N	63629-7311-1

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MCG
Approval Date:	Dec 12, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Dec 12, 2014	TE:	AB	RLD:	No

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