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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210821

TETRACAINE HYDROCHLORIDE (TETRACAINE HYDROCHLORIDE)
0.5%
Marketing Status: Prescription
Active Ingredient: TETRACAINE HYDROCHLORIDE
Proprietary Name: TETRACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; OPHTHALMIC
Strength: 0.5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210821
Product Number: 001
Approval Date: Mar 12, 2019
Applicant Holder Full Name: BAUSCH AND LOMB IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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