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Details for New Drug Application (NDA): 019668

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NDA 019668 describes CARDURA, which is a drug marketed by Pfizer and is included in two NDAs. It is available from three suppliers. Additional details are available on the CARDURA profile page.

The generic ingredient in CARDURA is doxazosin mesylate. There are thirteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.

Summary for NDA: 019668

Tradename:
CARDURA
Applicant:
Pfizer
Ingredient:
doxazosin mesylate
Patents:0
Therapeutic Class:Cardiovascular Agents
Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019668

Mechanism of ActionAdrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 019668

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARDURA
doxazosin mesylate
TABLET;ORAL 019668 NDA Roerig 0049-2750 0049-2750-41 100 BLISTER PACK in 1 CARTON (0049-2750-41) > 1 TABLET in 1 BLISTER PACK
CARDURA
doxazosin mesylate
TABLET;ORAL 019668 NDA Roerig 0049-2750 0049-2750-66 100 TABLET in 1 BOTTLE (0049-2750-66)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Nov 2, 1990TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Nov 2, 1990TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Nov 2, 1990TE:ABRLD:No

Expired Orange Book Patents for NDA: 019668

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CARDURA
doxazosin mesylate
TABLET;ORAL019668-001Nov 2, 19904,188,390► subscribe
Pfizer
CARDURA
doxazosin mesylate
TABLET;ORAL019668-004Nov 2, 19904,188,390► subscribe
Pfizer
CARDURA
doxazosin mesylate
TABLET;ORAL019668-003Nov 2, 19904,188,390► subscribe
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