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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208560

TESTOSTERONE (TESTOSTERONE)
1.62% (20.25MG/1.25GM ACTUATION)
Marketing Status: Prescription
Active Ingredient: TESTOSTERONE
Proprietary Name: TESTOSTERONE
Dosage Form; Route of Administration: GEL, METERED; TRANSDERMAL
Strength: 1.62% (20.25MG/1.25GM ACTUATION)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208560
Product Number: 001
Approval Date: Apr 10, 2019
Applicant Holder Full Name: LUPIN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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