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Generated: March 26, 2019

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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. Five 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
Medical Subject Heading (MeSH) Categories for 020700
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 0037-8110 0037-8110-06 6 POUCH in 1 CARTON (0037-8110-06) > 1 SUPPOSITORY in 1 POUCH (0037-8110-01)
MUSE alprostadil SUPPOSITORY;URETHRAL 020700 NDA Meda Pharmaceuticals 0037-8120 0037-8120-06 6 POUCH in 1 CARTON (0037-8120-06) > 1 SUPPOSITORY in 1 POUCH (0037-8120-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;URETHRALStrength0.125MG
Approval Date:Nov 19, 1996TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;URETHRALStrength0.25MG
Approval Date:Nov 19, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;URETHRALStrength0.5MG
Approval Date:Nov 19, 1996TE:RLD:Yes

Expired US Patents for NDA 020700

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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