Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079108
Company: IMPAX LABS INC
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/21/2015 | ORIG-4 | Approval |
Label is not available on this site. |
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| 08/05/2015 | ORIG-3 | Approval |
Label is not available on this site. |
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| 05/19/2014 | ORIG-2 | Approval |
Label is not available on this site. |
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| 11/21/2013 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/079108Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/17/2024 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 12/17/2024 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/17/2024 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 12/17/2024 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 11/29/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2019 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/28/2015 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/22/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | MEDICAP LABS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | PH HEALTH |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | MEDICAP LABS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | PH HEALTH |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | MEDICAP LABS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | PH HEALTH |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | MEDICAP LABS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | PH HEALTH |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078908 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |
CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210279 | ADARE PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 215523 | ASCENT PHARMS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213813 | GRANULES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079108 | IMPAX LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078992 | MEDICAP LABS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202842 | PH HEALTH |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202731 | TEVA PHARMS USA |
| FOCALIN XR | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021802 | SANDOZ |