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Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090455

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NDA 090455 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-four suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.

Summary for NDA: 090455

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090455

Ingredient-typeErgocalciferols

Suppliers and Packaging for NDA: 090455

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERGOCALCIFEROL
ergocalciferol
CAPSULE;ORAL 090455 ANDA Aidarex Pharmaceuticals LLC 53217-287 53217-287-08 8 CAPSULE in 1 BOTTLE (53217-287-08)
ERGOCALCIFEROL
ergocalciferol
CAPSULE;ORAL 090455 ANDA Aidarex Pharmaceuticals LLC 53217-287 53217-287-12 12 CAPSULE in 1 BOTTLE (53217-287-12)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50,000 IU
Approval Date:Aug 3, 2010TE:AARLD:No


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US Army
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