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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020700

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MUSE (ALPROSTADIL)
0.25MG
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: MUSE
Dosage Form; Route of Administration: SUPPOSITORY; URETHRAL
Strength: 0.25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020700
Product Number: 002
Approval Date: Nov 19, 1996
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information
MUSE (ALPROSTADIL)
0.5MG
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: MUSE
Dosage Form; Route of Administration: SUPPOSITORY; URETHRAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020700
Product Number: 003
Approval Date: Nov 19, 1996
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information
MUSE (ALPROSTADIL)
1MG
Marketing Status: Prescription
Active Ingredient: ALPROSTADIL
Proprietary Name: MUSE
Dosage Form; Route of Administration: SUPPOSITORY; URETHRAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020700
Product Number: 004
Approval Date: Nov 19, 1996
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information
MUSE (ALPROSTADIL)
0.125MG
Marketing Status: Discontinued
Active Ingredient: ALPROSTADIL
Proprietary Name: MUSE
Dosage Form; Route of Administration: SUPPOSITORY; URETHRAL
Strength: 0.125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020700
Product Number: 001
Approval Date: Nov 19, 1996
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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