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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079116

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NDA 079116 describes RAMIPRIL, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Invagen Pharms, Lupin, Ranbaxy Labs Ltd, Sandoz, Teva Pharms, Watson Labs, West-ward Pharms Int, Zydus Pharms Usa, Apotex Inc, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from thirty-four suppliers. Additional details are available on the RAMIPRIL profile page.

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

Summary for 079116

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 079116

Medical Subject Heading (MeSH) Categories for 079116

Suppliers and Packaging for NDA: 079116

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril CAPSULE;ORAL 079116 ANDA Apotex Corp. 60505-2875 60505-2875-5 500 CAPSULE in 1 BOTTLE (60505-2875-5)
RAMIPRIL ramipril CAPSULE;ORAL 079116 ANDA Apotex Corp. 60505-2875 60505-2875-8 1000 CAPSULE in 1 BOTTLE (60505-2875-8)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Jun 20, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jun 20, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 20, 2008TE:ABRLD:No


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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 verifification 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.

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