.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090704

« Back to Dashboard
NDA 090704 describes CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Macleods Pharms Ltd, Mylan Labs, Dr Reddys Labs Ltd, and Apotex Inc, and is included in four NDAs. It is available from four suppliers. Additional details are available on the CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE is candesartan cilexetil; hydrochlorothiazide. There are twenty-two drug master file entries for this compound. Seven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

Summary for NDA: 090704

Tradename:
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Applicant:
Mylan Labs
Ingredient:
candesartan cilexetil; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090704

Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 090704

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL 090704 ANDA Mylan Pharmaceuticals Inc. 0378-3001 0378-3001-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-3001-05)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL 090704 ANDA Mylan Pharmaceuticals Inc. 0378-3001 0378-3001-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-3001-77)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength16MG;12.5MG
Approval Date:Dec 4, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;12.5MG
Approval Date:Dec 4, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength32MG;25MG
Approval Date:Dec 4, 2012TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc