Details for New Drug Application (NDA): 204556

NDA 204556 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 204556

Tradename:	CALCITRIOL
Applicant:	Sun Pharm
Ingredient:	calcitriol
Patents:	0

Pharmacology for NDA: 204556

Medical Subject Heading (MeSH) Categories for 204556

Bone Density Conservation Agents

Calcium Channel Agonists

Vitamins

Suppliers and Packaging for NDA: 204556

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCITRIOL	calcitriol	CAPSULE;ORAL	204556	ANDA	Sun Pharmaceutical Industries, Inc.	62756-967	62756-967-18	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-18)
CALCITRIOL	calcitriol	CAPSULE;ORAL	204556	ANDA	Sun Pharmaceutical Industries, Inc.	62756-967	62756-967-83	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (62756-967-83)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.25MCG
Approval Date:	Feb 21, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	0.5MCG
Approval Date:	Feb 21, 2019	TE:	AB	RLD:	No

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