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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075201

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NDA 075201 describes INDAPAMIDE, which is a drug marketed by Actavis Elizabeth, Amerigen Pharms Ltd, Ani Pharms Inc, Mylan, Mylan Pharms Inc, Teva, Watson Labs, and Yaopharma Co Ltd, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the INDAPAMIDE profile page.

The generic ingredient in INDAPAMIDE is indapamide. There are seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the indapamide profile page.
Summary for 075201
Tradename:INDAPAMIDE
Applicant:Amerigen Pharms Ltd
Ingredient:indapamide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075201
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 075201
Suppliers and Packaging for NDA: 075201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDAPAMIDE indapamide TABLET;ORAL 075201 ANDA Amerigen Pharmaceuticals Inc. 43975-217 N 43975-217-11
INDAPAMIDE indapamide TABLET;ORAL 075201 ANDA Amerigen Pharmaceuticals Inc. 43975-217 N 43975-217-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Dec 4, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 4, 1998TE:ABRLD:No

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