Product Details for ANDA 211546
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
3.125MG;3.125MG;3.125MG;3.125MG
Marketing Status: Prescription
6.25MG;6.25MG;6.25MG;6.25MG
Marketing Status: Prescription
9.375MG;9.375MG;9.375MG;9.375MG
Marketing Status: Prescription
12.5MG;12.5MG;12.5MG;12.5MG
Marketing Status: Prescription
3.125MG;3.125MG;3.125MG;3.125MG
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: 3.125MG;3.125MG;3.125MG;3.125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A211546
Product Number: 001
Approval Date: Aug 31, 2023
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: 3.125MG;3.125MG;3.125MG;3.125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A211546
Product Number: 001
Approval Date: Aug 31, 2023
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: AB2
Application Number: A211546
Product Number: 002
Approval Date: Aug 31, 2023
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: AB2
Application Number: A211546
Product Number: 002
Approval Date: Aug 31, 2023
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
9.375MG;9.375MG;9.375MG;9.375MG
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: 9.375MG;9.375MG;9.375MG;9.375MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A211546
Product Number: 003
Approval Date: Aug 31, 2023
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: 9.375MG;9.375MG;9.375MG;9.375MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A211546
Product Number: 003
Approval Date: Aug 31, 2023
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information
12.5MG;12.5MG;12.5MG;12.5MG
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: 12.5MG;12.5MG;12.5MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A211546
Product Number: 004
Approval Date: Aug 31, 2023
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: 12.5MG;12.5MG;12.5MG;12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A211546
Product Number: 004
Approval Date: Aug 31, 2023
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Prescription
Patent and Exclusivity Information