Details for New Drug Application (NDA): 020379

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NDA 020379 describes CAVERJECT, which is a drug marketed by Pfizer and is included in three NDAs. It is available from one supplier. Additional details are available on the CAVERJECT profile page.

The generic ingredient in CAVERJECT is alprostadil. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

Summary for 020379

Tradename:	CAVERJECT
Applicant:	Pfizer
Ingredient:	alprostadil
Patents:	0

Pharmacology for NDA: 020379

Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Genitourinary Arterial Vasodilation Venous Vasodilation

Medical Subject Heading (MeSH) Categories for 020379

Platelet Aggregation Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 020379

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379	NDA	Pharmacia & Upjohn Company LLC	0009-3701	0009-3701-05	6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3701-05) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-3701-08)
CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379	NDA	Pharmacia & Upjohn Company LLC	0009-7686	0009-7686-04	6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-7686-04) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-7686-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.01MG/VIAL
Approval Date:	Jul 6, 1995	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.02MG/VIAL
Approval Date:	Jul 6, 1995	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.005MG/VIAL
Approval Date:	Jun 27, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020379

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-002	Jul 6, 1995	5,741,523	⤷ Subscribe
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-003	Jun 27, 1996	5,741,523	⤷ Subscribe
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-004	May 19, 1997	5,741,523	⤷ Subscribe
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-002	Jul 6, 1995	4,127,118	⤷ Subscribe
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-001	Jul 6, 1995	5,741,523	⤷ Subscribe
Pfizer	CAVERJECT	alprostadil	INJECTABLE;INJECTION	020379-001	Jul 6, 1995	4,127,118	⤷ Subscribe
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