Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090165
Company: SQUARE PHARMS
Company: SQUARE PHARMS
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 |
ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | No | No |
ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
08/28/2018 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090165Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/05/2022 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/02/2022 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/02/2022 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
02/05/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
02/04/2020 | SUPPL-1 | Labeling-Medication Guide, 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 |