Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202101
Company: ALEMBIC
Company: ALEMBIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | AB | No | No |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | AB | No | No |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/28/2015 | ORIG-1 | Approval | Not Applicable |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202101s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202101Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/27/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2016 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/28/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202101s000lbl.pdf |
ARIPIPRAZOLE
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 021436 | OTSUKA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 206251 | ACCORD HLTHCARE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 206174 | AJANTA PHARMA LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 202101 | ALEMBIC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 207105 | ALKEM LABS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 204838 | AMNEAL PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 078583 | APOTEX |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 203908 | AUROBINDO PHARMA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 091279 | BRECKENRIDGE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 205064 | HETERO LABS LTD V |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 205589 | LUPIN |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 204111 | MACLEODS PHARMS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 202683 | ORBION PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 205363 | PRINSTON INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 206383 | SCIEGEN PHARMS INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 213037 | SUNSHINE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 201519 | TORRENT |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 2MG | TABLET;ORAL | Prescription | No | AB | 203025 | UNICHEM |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021436 | OTSUKA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 206251 | ACCORD HLTHCARE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 206174 | AJANTA PHARMA LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 202101 | ALEMBIC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 207105 | ALKEM LABS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 204838 | AMNEAL PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 078583 | APOTEX |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 203908 | AUROBINDO PHARMA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 091279 | BRECKENRIDGE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 205064 | HETERO LABS LTD V |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 205589 | LUPIN |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 204111 | MACLEODS PHARMS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 202683 | ORBION PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 205363 | PRINSTON INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 206383 | SCIEGEN PHARMS INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 213037 | SUNSHINE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 201519 | TORRENT |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 5MG | TABLET;ORAL | Prescription | No | AB | 203025 | UNICHEM |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021436 | OTSUKA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 206251 | ACCORD HLTHCARE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 206174 | AJANTA PHARMA LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 202101 | ALEMBIC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 207105 | ALKEM LABS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 204838 | AMNEAL PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 078583 | APOTEX |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 203908 | AUROBINDO PHARMA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 091279 | BRECKENRIDGE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 205064 | HETERO LABS LTD V |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 205589 | LUPIN |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 204111 | MACLEODS PHARMS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 202683 | ORBION PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 205363 | PRINSTON INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 206383 | SCIEGEN PHARMS INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 213037 | SUNSHINE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 201519 | TORRENT |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 10MG | TABLET;ORAL | Prescription | No | AB | 203025 | UNICHEM |
TABLET;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 021436 | OTSUKA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 206251 | ACCORD HLTHCARE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 206174 | AJANTA PHARMA LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 202101 | ALEMBIC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 207105 | ALKEM LABS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 204838 | AMNEAL PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 078583 | APOTEX |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 203908 | AUROBINDO PHARMA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 091279 | BRECKENRIDGE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 205064 | HETERO LABS LTD V |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 205589 | LUPIN |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 204111 | MACLEODS PHARMS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 202683 | ORBION PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 205363 | PRINSTON INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 206383 | SCIEGEN PHARMS INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 201519 | TORRENT |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 15MG | TABLET;ORAL | Prescription | No | AB | 203025 | UNICHEM |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 021436 | OTSUKA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 206251 | ACCORD HLTHCARE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 206174 | AJANTA PHARMA LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 202101 | ALEMBIC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 207105 | ALKEM LABS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 204838 | AMNEAL PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 078583 | APOTEX |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 203908 | AUROBINDO PHARMA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 091279 | BRECKENRIDGE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 205064 | HETERO LABS LTD V |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 205589 | LUPIN |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 204111 | MACLEODS PHARMS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 202683 | ORBION PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 205363 | PRINSTON INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 206383 | SCIEGEN PHARMS INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 201519 | TORRENT |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 20MG | TABLET;ORAL | Prescription | No | AB | 203025 | UNICHEM |
TABLET;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ABILIFY | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 021436 | OTSUKA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 206251 | ACCORD HLTHCARE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 206174 | AJANTA PHARMA LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 202101 | ALEMBIC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 207105 | ALKEM LABS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 204838 | AMNEAL PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 078583 | APOTEX |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 203908 | AUROBINDO PHARMA |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 091279 | BRECKENRIDGE |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 205064 | HETERO LABS LTD V |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 205589 | LUPIN |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 204111 | MACLEODS PHARMS LTD |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 202683 | ORBION PHARMS |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 205363 | PRINSTON INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 206383 | SCIEGEN PHARMS INC |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 201519 | TORRENT |
| ARIPIPRAZOLE | ARIPIPRAZOLE | 30MG | TABLET;ORAL | Prescription | No | AB | 203025 | UNICHEM |