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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021015."



Active Ingredient: TESTOSTERONE
Dosage Form;Route: GEL;TRANSDERMAL
Proprietary Name: ANDROGEL
Applicant: ABBVIE
Strength: 25MG/2.5GM PACKET
Application Number: N021015
Product Number: 001
Approval Date: Feb 28, 2000
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: TESTOSTERONE
Dosage Form;Route: GEL;TRANSDERMAL
Proprietary Name: ANDROGEL
Applicant: ABBVIE
Strength: 50MG/5GM PACKET
Application Number: N021015
Product Number: 002
Approval Date: Feb 28, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: TESTOSTERONE
Dosage Form;Route: GEL, METERED;TRANSDERMAL
Proprietary Name: ANDROGEL
Applicant: ABBVIE
Strength: 12.5MG/1.25GM ACTUATION
Application Number: N021015
Product Number: 003
Approval Date: Sep 26, 2003
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through June 2014
Patent and Generic Drug Product Data Last Updated July 29, 2014

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