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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 "040422."



Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Applicant: BARR
Strength: 1.25MG;1.25MG;1.25MG;1.25MG
Application Number: A040422
Product Number: 001
Approval Date: Feb 11, 2002
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Applicant: BARR
Strength: 2.5MG;2.5MG;2.5MG;2.5MG
Application Number: A040422
Product Number: 002
Approval Date: Feb 11, 2002
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Applicant: BARR
Strength: 5MG;5MG;5MG;5MG
Application Number: A040422
Product Number: 003
Approval Date: Feb 11, 2002
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Applicant: BARR
Strength: 7.5MG;7.5MG;7.5MG;7.5MG
Application Number: A040422
Product Number: 004
Approval Date: Feb 11, 2002
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Applicant: BARR
Strength: 1.875MG;1.875MG;1.875MG;1.875MG
Application Number: A040422
Product Number: 005
Approval Date: Mar 19, 2003
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Applicant: BARR
Strength: 3.125MG;3.125MG;3.125MG;3.125MG
Application Number: A040422
Product Number: 006
Approval Date: Mar 19, 2003
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: TABLET;ORAL
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Applicant: BARR
Strength: 3.75MG;3.75MG;3.75MG;3.75MG
Application Number: A040422
Product Number: 007
Approval Date: Mar 19, 2003
Reference Listed Drug No
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 July 2014
Patent and Generic Drug Product Data Last Updated August 29, 2014

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