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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Healthtrust
Chubb
Fuji
Medtronic
Deloitte
QuintilesIMS
Cantor Fitzgerald
Queensland Health

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084217

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NDA 084217 describes CHLOROTHIAZIDE, which is a drug marketed by Abc Holding, Hikma Intl Pharms, Lederle, Mylan, Sandoz, Watson Labs, Hikma Pharms, Fresenius Kabi Usa, Luitpold, Mylan Institutional, Sagent Pharms, and Sun Pharma Global, and is included in twenty-three NDAs. It is available from three suppliers. Additional details are available on the CHLOROTHIAZIDE profile page.

The generic ingredient in CHLOROTHIAZIDE is chlorothiazide sodium. There are forty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.
Summary for 084217
Tradename:CHLOROTHIAZIDE
Applicant:Mylan
Ingredient:chlorothiazide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 084217
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 084217
Suppliers and Packaging for NDA: 084217
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 084217 ANDA Mylan Pharmaceuticals Inc. 0378-0150 0378-0150-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0150-01)
CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 084217 ANDA Mylan Pharmaceuticals Inc. 0378-0162 0378-0162-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0162-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Medtronic
Baxter
AstraZeneca
Moodys
Colorcon
Deloitte
Cipla

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