Product Details for ANDA 211547
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
1.25MG;1.25MG;1.25MG;1.25MG
Marketing Status: Prescription
2.5MG;2.5MG;2.5MG;2.5MG
Marketing Status: Prescription
3.75MG;3.75MG;3.75MG;3.75MG
Marketing Status: Prescription
5MG;5MG;5MG;5MG
Marketing Status: Prescription
6.25MG;6.25MG;6.25MG;6.25MG
Marketing Status: Prescription
7.5MG;7.5MG;7.5MG;7.5MG
Marketing Status: Prescription
1.25MG;1.25MG;1.25MG;1.25MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 1.25MG;1.25MG;1.25MG;1.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 001
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 1.25MG;1.25MG;1.25MG;1.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 001
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
2.5MG;2.5MG;2.5MG;2.5MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 2.5MG;2.5MG;2.5MG;2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 002
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 2.5MG;2.5MG;2.5MG;2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 002
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
3.75MG;3.75MG;3.75MG;3.75MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 3.75MG;3.75MG;3.75MG;3.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 003
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 3.75MG;3.75MG;3.75MG;3.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 003
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG;5MG;5MG;5MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 5MG;5MG;5MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 004
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 5MG;5MG;5MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 004
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
6.25MG;6.25MG;6.25MG;6.25MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 6.25MG;6.25MG;6.25MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 005
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 6.25MG;6.25MG;6.25MG;6.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 005
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
7.5MG;7.5MG;7.5MG;7.5MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7.5MG;7.5MG;7.5MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 006
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7.5MG;7.5MG;7.5MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A211547
Product Number: 006
Approval Date: Apr 22, 2019
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information