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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075765

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NDA 075765 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 075765
Formulation / Manufacturing:see details
Pharmacology for NDA: 075765
Medical Subject Heading (MeSH) Categories for 075765
Suppliers and Packaging for NDA: 075765
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCITRIOL calcitriol CAPSULE;ORAL 075765 ANDA Teva Pharmaceuticals USA, Inc. 0093-7352 0093-7352-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-7352-01)
CALCITRIOL calcitriol CAPSULE;ORAL 075765 ANDA Teva Pharmaceuticals USA, Inc. 0093-7353 0093-7353-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-7353-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.25MCG
Approval Date:Oct 12, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MCG
Approval Date:Oct 12, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Farmers Insurance

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