Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022483

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ZYCLARA (IMIQUIMOD)
2.5%
Marketing Status: Prescription

Active Ingredient: IMIQUIMOD
Proprietary Name: ZYCLARA
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 2.5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022483
Product Number: 002
Approval Date: Jul 15, 2011
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYCLARA (IMIQUIMOD)
3.75%
Marketing Status: Prescription

Active Ingredient: IMIQUIMOD
Proprietary Name: ZYCLARA
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 3.75%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022483
Product Number: 001
Approval Date: Mar 25, 2010
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information