Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209253
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPHETAMINE | AMPHETAMINE | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| AMPHETAMINE | AMPHETAMINE | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| AMPHETAMINE | AMPHETAMINE | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| AMPHETAMINE | AMPHETAMINE | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| AMPHETAMINE | AMPHETAMINE | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| AMPHETAMINE | AMPHETAMINE | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, 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 |
|---|---|---|---|---|---|---|---|
| 06/22/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209253Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/08/2025 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/08/2025 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
AMPHETAMINE
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 3.1MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | AMPHETAMINE | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204326 | NEOS THERAPS |
| AMPHETAMINE | AMPHETAMINE | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209253 | ACTAVIS LABS FL INC |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 6.3MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | AMPHETAMINE | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204326 | NEOS THERAPS |
| AMPHETAMINE | AMPHETAMINE | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209253 | ACTAVIS LABS FL INC |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 9.4MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | AMPHETAMINE | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204326 | NEOS THERAPS |
| AMPHETAMINE | AMPHETAMINE | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209253 | ACTAVIS LABS FL INC |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 12.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | AMPHETAMINE | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204326 | NEOS THERAPS |
| AMPHETAMINE | AMPHETAMINE | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209253 | ACTAVIS LABS FL INC |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 15.7MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | AMPHETAMINE | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204326 | NEOS THERAPS |
| AMPHETAMINE | AMPHETAMINE | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209253 | ACTAVIS LABS FL INC |
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 18.8MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | AMPHETAMINE | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 204326 | NEOS THERAPS |
| AMPHETAMINE | AMPHETAMINE | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209253 | ACTAVIS LABS FL INC |