Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215997
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/27/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2024 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
CAPSULE, EXTENDED RELEASE;ORAL; 3.125MG;3.125MG;3.125MG;3.125MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
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 | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
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 | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
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 | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 6.25MG;6.25MG;6.25MG;6.25MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 9.375MG;9.375MG;9.375MG;9.375MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 12.5MG;12.5MG;12.5MG;12.5MG
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |