Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090533
Company: AZURITY
Company: AZURITY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | AA | No | No |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | AA | No | No |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 7.5MG | TABLET;ORAL | Prescription | AA | No | No |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | AA | No | No |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | TABLET;ORAL | Prescription | AA | No | No |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 20MG | TABLET;ORAL | Prescription | AA | No | No |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 30MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 10/25/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/17/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/30/2015 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
DEXTROAMPHETAMINE SULFATE
TABLET;ORAL; 2.5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AA | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |
TABLET;ORAL; 5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 202893 | AUROLIFE PHARMA LLC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 203548 | AVANTHI INC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 040361 | BARR |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 204330 | NOVEL LABS INC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 210059 | NUVO PHARM |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 040436 | SPECGX LLC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |
TABLET;ORAL; 7.5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 7.5MG | TABLET;ORAL | Prescription | No | AA | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 7.5MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |
TABLET;ORAL; 10MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 202893 | AUROLIFE PHARMA LLC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 203548 | AVANTHI INC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 040361 | BARR |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 204330 | NOVEL LABS INC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 210059 | NUVO PHARM |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 040436 | SPECGX LLC |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 10MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |
TABLET;ORAL; 15MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | TABLET;ORAL | Prescription | No | AA | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 15MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |
TABLET;ORAL; 20MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 20MG | TABLET;ORAL | Prescription | No | AA | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 20MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |
TABLET;ORAL; 30MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 30MG | TABLET;ORAL | Prescription | No | AA | 090533 | AZURITY |
| DEXTROAMPHETAMINE SULFATE | DEXTROAMPHETAMINE SULFATE | 30MG | TABLET;ORAL | Prescription | No | AA | 212160 | WINDER LABS LLC |