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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091220

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NDA 091220 describes GLIMEPIRIDE, which is a drug marketed by Teva, Carlsbad, Indoco Remedies, Micro Labs Ltd India, Mylan, Hikma Pharms, Aurobindo Pharma Ltd, Ranbaxy, Prinston Inc, Epic Pharma Llc, Ranbaxy Labs Ltd, Watson Labs, Accord Hlthcare, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, and Invagen Pharms, and is included in seventeen NDAs. It is available from forty-two 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-three suppliers are listed for this compound. Additional details are available on the glimepiride profile page.

Summary for NDA: 091220

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

Pharmacology for NDA: 091220

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 091220

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIMEPIRIDE
glimepiride
TABLET;ORAL 091220 ANDA Aidarex Pharmaceuticals LLC 33261-831 33261-831-99 180 TABLET in 1 BOTTLE, PLASTIC (33261-831-99)
GLIMEPIRIDE
glimepiride
TABLET;ORAL 091220 ANDA Micro Labs Limited 42571-100 42571-100-01 100 TABLET in 1 BOTTLE (42571-100-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 29, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 29, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jun 29, 2012TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Express Scripts
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Queensland Health
Daiichi Sankyo
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McKesson
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Boehringer Ingelheim
Julphar
McKinsey

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