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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021302

ELIDEL (PIMECROLIMUS)
1%
Marketing Status: Prescription
Active Ingredient: PIMECROLIMUS
Proprietary Name: ELIDEL
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021302
Product Number: 001
Approval Date: Dec 13, 2001
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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