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Serving 500+ biopharmaceutical companies globally:

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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091004

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NDA 091004 describes ERGOCALCIFEROL, which is a drug marketed by Sigmapharm Labs Llc, Orit Labs Llc, Strides Pharma, and Sun Pharm Inds Inc, and is included in four NDAs. It is available from twenty-five suppliers. Additional details are available on the ERGOCALCIFEROL profile page.

The generic ingredient in ERGOCALCIFEROL is ergocalciferol. There are five drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.

Summary for NDA: 091004

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 091004

Ingredient-typeErgocalciferols

Suppliers and Packaging for NDA: 091004

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERGOCALCIFEROL
ergocalciferol
CAPSULE;ORAL 091004 ANDA SigmaPharm Laboratories, LLC 42794-006 42794-006-02 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (42794-006-02)
ERGOCALCIFEROL
ergocalciferol
CAPSULE;ORAL 091004 ANDA Unit Dose Services 50436-3622 50436-3622-4 4 CAPSULE, LIQUID FILLED in 1 BOTTLE (50436-3622-4)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50,000 IU
Approval Date:Jul 14, 2010TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Johnson and Johnson
QuintilesIMS
US Army
Covington
Novartis
McKinsey
Teva
UBS

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