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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050777

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PROTOPIC (TACROLIMUS)
0.03%
Marketing Status: Prescription
Active Ingredient: TACROLIMUS
Proprietary Name: PROTOPIC
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 0.03%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050777
Product Number: 001
Approval Date: Dec 8, 2000
Applicant Holder Full Name: LEO PHARMA AS
Marketing Status:  Prescription
Patent and Exclusivity Information
PROTOPIC (TACROLIMUS)
0.1%
Marketing Status: Prescription
Active Ingredient: TACROLIMUS
Proprietary Name: PROTOPIC
Dosage Form; Route of Administration: OINTMENT; TOPICAL
Strength: 0.1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050777
Product Number: 002
Approval Date: Dec 8, 2000
Applicant Holder Full Name: LEO PHARMA AS
Marketing Status:  Prescription
Patent and Exclusivity Information
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