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Generated: October 18, 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 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-two 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-typeCholecalciferol
Medical Subject Heading (MeSH) Categories for 091356
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 Heritage Pharmaceuticals Inc. 23155-662 23155-662-01 100 CAPSULE in 1 BOTTLE (23155-662-01)

Profile for product number 001

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

Profile for product number 002

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

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