Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208861
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB3 | 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 |
|---|---|---|---|---|---|---|---|
| 12/13/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208861Orig1s000TAltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/16/2024 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/12/2023 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/12/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 205831 | RHODES PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208861 | ACTAVIS ELIZABETH |
CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | METHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 205831 | RHODES PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208861 | ACTAVIS ELIZABETH |
CAPSULE, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 205831 | RHODES PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208861 | ACTAVIS ELIZABETH |
CAPSULE, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 205831 | RHODES PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208861 | ACTAVIS ELIZABETH |
CAPSULE, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 205831 | RHODES PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208861 | ACTAVIS ELIZABETH |
CAPSULE, EXTENDED RELEASE;ORAL; 50MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 205831 | RHODES PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208861 | ACTAVIS ELIZABETH |
CAPSULE, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB3
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APTENSIO XR | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB3 | 205831 | RHODES PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB3 | 208861 | ACTAVIS ELIZABETH |