Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075356
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/2003 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/75356ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/21/2020 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2014 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2011 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2012 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2011 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2010 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2009 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/14/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/05/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 02/05/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/05/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 02/05/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/29/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/29/2006 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/27/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/02/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
PAROXETINE HYDROCHLORIDE
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |
TABLET;ORAL; EQ 30MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 203854 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 075356 | APOTEX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 078406 | AUROBINDO PHARMA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076618 | CHARTWELL RX |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 078902 | MYLAN |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076968 | OXFORD PHARMS |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 211248 | YILING |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077584 | ZYDUS PHARMS USA |
| PAXIL | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020031 | APOTEX |