Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202645
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 08/03/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202645Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/16/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
PALIPERIDONE
TABLET, EXTENDED RELEASE;ORAL; 1.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202645 | ACTAVIS LABS FL INC |
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204707 | AMNEAL PHARMS |
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216174 | ASCENT PHARMS INC |
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212807 | CSPC OUYI |
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204452 | INVENTIA |
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208643 | LUPIN LTD |
| PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203802 | RK PHARMA |
| PALIPERIDONE | PALIPERIDONE | 1.5mg | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205618 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021999 | JANSSEN PHARMS |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202645 | ACTAVIS LABS FL INC |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204707 | AMNEAL PHARMS |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216174 | ASCENT PHARMS INC |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212807 | CSPC OUYI |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204452 | INVENTIA |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208643 | LUPIN LTD |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203802 | RK PHARMA |
| PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205618 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 6MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021999 | JANSSEN PHARMS |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202645 | ACTAVIS LABS FL INC |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204707 | AMNEAL PHARMS |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216174 | ASCENT PHARMS INC |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212807 | CSPC OUYI |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204452 | INVENTIA |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208643 | LUPIN LTD |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203802 | RK PHARMA |
| PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205618 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 9MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| INVEGA | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021999 | JANSSEN PHARMS |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202645 | ACTAVIS LABS FL INC |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204707 | AMNEAL PHARMS |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216174 | ASCENT PHARMS INC |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212807 | CSPC OUYI |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204452 | INVENTIA |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208643 | LUPIN LTD |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203802 | RK PHARMA |
| PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205618 | SUN PHARM |