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Details for New Drug Application (NDA): 077102

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NDA 077102 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 thirteen 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 NDA: 077102

Formulation / Manufacturing:see details

Pharmacology for NDA: 077102


Suppliers and Packaging for NDA: 077102

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 077102 ANDA West-ward Pharmaceutical Corp 0143-9728 0143-9728-05 1 mL in 1 AMPULE (0143-9728-05)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.001MG/ML
Approval Date:Feb 8, 2006TE:RLD: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.