Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021015

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ANDROGEL (TESTOSTERONE)
25MG/2.5GM PACKET Marketing Status: Prescription

Active Ingredient: TESTOSTERONE
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 25MG/2.5GM PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021015
Product Number: 001
Approval Date: Feb 28, 2000
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ANDROGEL (TESTOSTERONE)
50MG/5GM PACKET Marketing Status: Prescription

Active Ingredient: TESTOSTERONE
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL; TRANSDERMAL
Strength: 50MG/5GM PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB1
Application Number: N021015
Product Number: 002
Approval Date: Feb 28, 2000
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ANDROGEL (TESTOSTERONE)
12.5MG/1.25GM ACTUATION Marketing Status: Prescription

Active Ingredient: TESTOSTERONE
Proprietary Name: ANDROGEL
Dosage Form; Route of Administration: GEL, METERED; TRANSDERMAL
Strength: 12.5MG/1.25GM ACTUATION
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021015
Product Number: 003
Approval Date: Sep 26, 2003
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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