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Details for New Drug Application (NDA): 207672

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NDA 207672 describes PARICALCITOL, which is a drug marketed by Sandoz Canada Inc, Lotus Pharm Co Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Rising Pharms Inc, Amneal Pharms, Teva Pharms Usa, Bionpharma Inc, Marksans Pharma, Hospira Inc, Aurobindo Pharma Ltd, and Accord Hlthcare, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the PARICALCITOL profile page.

The generic ingredient in PARICALCITOL is paricalcitol. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the paricalcitol profile page.

Summary for NDA: 207672

Aurobindo Pharma Ltd
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for NDA: 207672


Suppliers and Packaging for NDA: 207672

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 207672 ANDA Aurobindo Pharma Limited 65862-936 65862-936-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (65862-936-30)
CAPSULE;ORAL 207672 ANDA Aurobindo Pharma Limited 65862-937 65862-937-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (65862-937-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:Jan 14, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:Jan 14, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength4MCG
Approval Date:Jan 14, 2016TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.