Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090533

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DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
2.5MG
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090533
Product Number: 001
Approval Date: Oct 25, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
5MG
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090533
Product Number: 002
Approval Date: Oct 25, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
7.5MG
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090533
Product Number: 003
Approval Date: Oct 25, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
10MG
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090533
Product Number: 004
Approval Date: Oct 25, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
15MG
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090533
Product Number: 005
Approval Date: Oct 25, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
20MG
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090533
Product Number: 006
Approval Date: Oct 25, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
30MG
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMPHETAMINE SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A090533
Product Number: 007
Approval Date: Oct 25, 2011
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information