Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205673
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
10/31/2017 | 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 |
---|---|---|---|---|---|
03/11/2024 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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03/11/2024 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 017078 | IMPAX LABS INC |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203901 | ACTAVIS ELIZABETH |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076353 | SPECGX LLC |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205673 | STRIDES PHARMA |
CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 017078 | IMPAX LABS INC |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203901 | ACTAVIS ELIZABETH |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076353 | SPECGX LLC |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205673 | STRIDES PHARMA |
CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXEDRINE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 017078 | IMPAX LABS INC |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203901 | ACTAVIS ELIZABETH |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076353 | SPECGX LLC |
DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205673 | STRIDES PHARMA |