Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210354
Company: ASCENT PHARMS INC
Company: ASCENT PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/29/2017 | 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 |
---|---|---|---|---|---|
10/13/2023 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/12/2023 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/25/2021 | SUPPL-3 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
METHYLPHENIDATE HYDROCHLORIDE
TABLET, CHEWABLE;ORAL; 2.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 210354 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 205756 | RISING |
TABLET, CHEWABLE;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, CHEWABLE;ORAL | Prescription | No | AB | 210354 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 205756 | RISING |
TABLET, CHEWABLE;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, CHEWABLE;ORAL | Prescription | No | AB | 210354 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 205756 | RISING |