Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021463

10MG/0.5GM ACTUATION Marketing Status: Prescription

Active Ingredient: TESTOSTERONE
Proprietary Name: FORTESTA
Dosage Form; Route of Administration: GEL, METERED; TRANSDERMAL
Strength: 10MG/0.5GM ACTUATION
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021463
Product Number: 001
Approval Date: Dec 29, 2010
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Prescription
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