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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050805

Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE
Proprietary Name: ORACEA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050805
Product Number: 001
Approval Date: May 26, 2006
Applicant Holder Full Name: GALDERMA LABORATORIES LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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