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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209253

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AMPHETAMINE (AMPHETAMINE)
EQ 3.1MG BASE
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE
Proprietary Name: AMPHETAMINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 3.1MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209253
Product Number: 001
Approval Date: Jun 22, 2023
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMPHETAMINE (AMPHETAMINE)
EQ 6.3MG BASE
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE
Proprietary Name: AMPHETAMINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 6.3MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209253
Product Number: 002
Approval Date: Jun 22, 2023
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMPHETAMINE (AMPHETAMINE)
EQ 9.4MG BASE
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE
Proprietary Name: AMPHETAMINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 9.4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209253
Product Number: 003
Approval Date: Jun 22, 2023
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMPHETAMINE (AMPHETAMINE)
EQ 12.5MG BASE
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE
Proprietary Name: AMPHETAMINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209253
Product Number: 004
Approval Date: Jun 22, 2023
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMPHETAMINE (AMPHETAMINE)
EQ 15.7MG BASE
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE
Proprietary Name: AMPHETAMINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 15.7MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209253
Product Number: 005
Approval Date: Jun 22, 2023
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
AMPHETAMINE (AMPHETAMINE)
EQ 18.8MG BASE
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE
Proprietary Name: AMPHETAMINE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 18.8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A209253
Product Number: 006
Approval Date: Jun 22, 2023
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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