Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211779
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 | 5MG | TABLET;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;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 |
---|---|---|---|---|---|---|---|
10/04/2019 | 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 |
---|---|---|---|---|---|
12/16/2022 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2022 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
METHYLPHENIDATE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |
TABLET;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |
TABLET;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |