Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212288
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, 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 |
---|---|---|---|---|---|---|---|
10/06/2020 | 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 |
---|---|---|---|---|---|
06/25/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
METHYLPHENIDATE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLIN ER | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075629 | SPECGX LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207488 | ABHAI LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212288 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210992 | GRANULES |