Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204570

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TESTOSTERONE (TESTOSTERONE)
1.62% (40.5MG/2.5GM PACKET)
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE
Proprietary Name: TESTOSTERONE
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 1.62% (40.5MG/2.5GM PACKET)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A204570
Product Number: 003
Approval Date: Jul 17, 2020
Applicant Holder Full Name: ACTAVIS LABORATORIES UT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TESTOSTERONE (TESTOSTERONE)
1.62% (20.25MG/1.25GM PACKET)
Marketing Status: Prescription

Active Ingredient: TESTOSTERONE
Proprietary Name: TESTOSTERONE
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 1.62% (20.25MG/1.25GM PACKET)
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A204570
Product Number: 002
Approval Date: Jul 17, 2020
Applicant Holder Full Name: ACTAVIS LABORATORIES UT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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: A204570
Product Number: 001
Approval Date: Apr 10, 2019
Applicant Holder Full Name: ACTAVIS LABORATORIES UT INC
Marketing Status:  Prescription
Patent and Exclusivity Information