Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207240
Company: SCIEGEN PHARMS INC
Company: SCIEGEN PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
04/18/2018 | 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 |
---|---|---|---|---|---|
02/01/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
02/05/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
ARIPIPRAZOLE
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202102 | ALEMBIC |
ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202547 | ORBION PHARMS |
ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 207240 | SCIEGEN PHARMS INC |
ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090165 | SQUARE PHARMS |
TABLET, ORALLY DISINTEGRATING;ORAL; 15MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202102 | ALEMBIC |
ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 202547 | ORBION PHARMS |
ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 207240 | SCIEGEN PHARMS INC |
ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090165 | SQUARE PHARMS |