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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215408

DOXEPIN HYDROCHLORIDE (DOXEPIN HYDROCHLORIDE)
5%
Marketing Status: Prescription
Active Ingredient: DOXEPIN HYDROCHLORIDE
Proprietary Name: DOXEPIN HYDROCHLORIDE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A215408
Product Number: 001
Approval Date: Feb 17, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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