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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204399

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VOGELXO (TESTOSTERONE)
50MG/5GM PACKET
Marketing Status: Prescription
Active Ingredient: TESTOSTERONE
Proprietary Name: VOGELXO
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 50MG/5GM PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: N204399
Product Number: 002
Approval Date: Jun 4, 2014
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
VOGELXO (TESTOSTERONE)
12.5MG/1.25GM ACTUATION
Marketing Status: Prescription
Active Ingredient: TESTOSTERONE
Proprietary Name: VOGELXO
Dosage Form; Route of Administration: GEL, METERED; TRANSDERMAL
Strength: 12.5MG/1.25GM ACTUATION
Reference Listed Drug: No
Reference Standard: No
TE Code: BX
Application Number: N204399
Product Number: 003
Approval Date: Jun 4, 2014
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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