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Generated: May 25, 2017

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Details for New Drug Application (NDA): 091356

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

Summary for NDA: 091356

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 091356

Ingredient-typeCholecalciferol

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 17856-0723-1 100 DOSE PACK in 1 CONTAINER (17856-0723-1) > 1 CAPSULE in 1 DOSE PACK
CALCITRIOL
calcitriol
CAPSULE;ORAL 091356 ANDA Strides Shasun Limited 64380-723 64380-723-04 30 CAPSULE in 1 CONTAINER (64380-723-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:Dec 12, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Dec 12, 2014TE:ABRLD:No


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