Details for New Drug Application (NDA): 091356

NDA 091356 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Anda Repository, and Rising, and is included in eighteen NDAs. It is available from twenty 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-four 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

Pharmacology for NDA: 091356

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	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-662	23155-662-01	100 CAPSULE in 1 BOTTLE (23155-662-01)
CALCITRIOL	calcitriol	CAPSULE;ORAL	091356	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-662	23155-662-03	30 CAPSULE in 1 BOTTLE (23155-662-03)

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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