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Last Updated: July 21, 2024

Details for New Drug Application (NDA): 090455


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NDA 090455 describes ERGOCALCIFEROL, which is a drug marketed by Chartwell Rx, Puracap Pharm Llc, Sigmapharm Labs Llc, Strides Pharma, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from eighteen suppliers. Additional details are available on the ERGOCALCIFEROL profile page.

The generic ingredient in ERGOCALCIFEROL is ergocalciferol. There are six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
Summary for 090455
Tradename:ERGOCALCIFEROL
Applicant:Strides Pharma
Ingredient:ergocalciferol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090455
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 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-809 23155-809-01 100 CAPSULE in 1 BOTTLE, PLASTIC (23155-809-01)
ERGOCALCIFEROL ergocalciferol CAPSULE;ORAL 090455 ANDA AvPAK 50268-297 50268-297-15 50 BLISTER PACK in 1 BOX (50268-297-15) / 1 CAPSULE in 1 BLISTER PACK (50268-297-11)

Profile for product number 001

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

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