You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 21, 2024

Details for New Drug Application (NDA): 090455

✉ Email this page to a colleague

« Back to Dashboard

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
Applicant:Strides Pharma
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.