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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021214

RESCULA (UNOPROSTONE ISOPROPYL)
0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: UNOPROSTONE ISOPROPYL
Proprietary Name: RESCULA
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021214
Product Number: 001
Approval Date: Aug 3, 2000
Applicant Holder Full Name: SUCAMPO PHARMA AMERICAS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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