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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
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Cipla
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Generated: December 13, 2017

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:1
Applicant:1
Ingredient:1
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 Bryant Ranch Prepack 63629-7311 63629-7311-3 28 CAPSULE in 1 BOTTLE (63629-7311-3)

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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
UBS
QuintilesIMS
AstraZeneca
Argus Health
Dow
Express Scripts
Covington
Boehringer Ingelheim

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