Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077873
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/29/2007 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077873s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077873Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/04/2021 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/04/2021 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2013 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/27/2011 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2011 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2010 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/02/2010 | SUPPL-11 | Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/22/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/17/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/26/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
PAROXETINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; EQ 12.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077873 | AUROBINDO PHARMA USA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212645 | CADILA PHARMS LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213485 | CSPC OUYI |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204744 | LANNETT CO INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204134 | LUPIN LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209748 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209293 | SCIECURE PHARMA INC |
| PAXIL CR | PAROXETINE HYDROCHLORIDE | EQ 12.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020936 | APOTEX |
TABLET, EXTENDED RELEASE;ORAL; EQ 25MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077873 | AUROBINDO PHARMA USA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212645 | CADILA PHARMS LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213485 | CSPC OUYI |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204744 | LANNETT CO INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204134 | LUPIN LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209748 | PRINSTON INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209293 | SCIECURE PHARMA INC |
| PAXIL CR | PAROXETINE HYDROCHLORIDE | EQ 25MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020936 | APOTEX |