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US Department of Justice

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086028

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NDA 086028 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 086028
Tradename:CHLOROTHIAZIDE
Applicant:Hikma Intl Pharms
Ingredient:chlorothiazide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 086028
Ingredient-typeThiazides
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 086028
Suppliers and Packaging for NDA: 086028
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 086028 ANDA West-ward Pharmaceutical Corp 0143-1209 N 0143-1209-01
CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 086028 ANDA West-ward Pharmaceutical Corp 0143-1209 N 0143-1209-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Jul 14, 1982TE:RLD:No

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