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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cipla
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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077624

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NDA 077624 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Invagen Pharms, Micro Labs Ltd India, Mylan, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, and Watson Labs, and is included in seventeen NDAs. It is available from forty-one suppliers. Additional details are available on the GLIMEPIRIDE profile page.

The generic ingredient in GLIMEPIRIDE is glimepiride. There are fourteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the glimepiride profile page.

Summary for 077624

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 077624

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 077624

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE glimepiride TABLET;ORAL 077624 ANDA Mylan Pharmaceuticals Inc. 0378-4011 0378-4011-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-4011-01)
GLIMEPIRIDE glimepiride TABLET;ORAL 077624 ANDA Mylan Pharmaceuticals Inc. 0378-4012 0378-4012-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-4012-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 28, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 28, 2005TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Nov 28, 2005TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
Cantor Fitzgerald
Queensland Health
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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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