Details for New Drug Application (NDA): 020700

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NDA 020700 describes MUSE, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. Additional details are available on the MUSE profile page.

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

Summary for 020700

Tradename:	MUSE
Applicant:	Mylan Speciality Lp
Ingredient:	alprostadil
Patents:	0

Pharmacology for NDA: 020700

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

Medical Subject Heading (MeSH) Categories for 020700

Platelet Aggregation Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 020700

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700	NDA	Meda Pharmaceuticals Inc.	0037-8120	0037-8120-06	6 POUCH in 1 CARTON (0037-8120-06) / 1 SUPPOSITORY in 1 POUCH (0037-8120-01)
MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700	NDA	Meda Pharmaceuticals Inc.	0037-8120	0037-8120-56	6 POUCH in 1 CARTON (0037-8120-56) / 1 SUPPOSITORY in 1 POUCH (0037-8120-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;URETHRAL			Strength	0.125MG
Approval Date:	Nov 19, 1996	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;URETHRAL			Strength	0.25MG
Approval Date:	Nov 19, 1996	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;URETHRAL			Strength	0.5MG
Approval Date:	Nov 19, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020700

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996	See Plans and Pricing	See Plans and Pricing
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	See Plans and Pricing	See Plans and Pricing
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	See Plans and Pricing	See Plans and Pricing
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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