➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Boehringer Ingelheim
Express Scripts
McKinsey
Medtronic

Last Updated: August 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200895

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 200895 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Limited, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Hisun Pharm Hangzhou, Ivax Sub Teva Pharms, Lupin, Micro Labs, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in sixteen NDAs. It is available from thirty-six suppliers. Additional details are available on the SIMVASTATIN profile page.

The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 200895
Tradename:SIMVASTATIN
Applicant:Hetero Labs Ltd Iii
Ingredient:simvastatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200895
Suppliers and Packaging for NDA: 200895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 200895 ANDA Camber Pharmaceuticals, Inc. 31722-510 31722-510-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-510-01)
SIMVASTATIN simvastatin TABLET;ORAL 200895 ANDA Camber Pharmaceuticals, Inc. 31722-510 31722-510-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-510-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 25, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 25, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 25, 2014TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Dow
Baxter
Mallinckrodt
Johnson and Johnson

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.