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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022221

AKTEN (LIDOCAINE HYDROCHLORIDE)
3.5%
Marketing Status: Prescription
Active Ingredient: LIDOCAINE HYDROCHLORIDE
Proprietary Name: AKTEN
Dosage Form; Route of Administration: GEL; OPHTHALMIC
Strength: 3.5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022221
Product Number: 001
Approval Date: Oct 7, 2008
Applicant Holder Full Name: THEA PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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