Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213485
Company: CSPC OUYI
Company: CSPC OUYI
| 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 |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG 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 |
|---|---|---|---|---|---|---|---|
| 02/16/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2024 | SUPPL-1 | Labeling-Package Insert |
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 |
TABLET, EXTENDED RELEASE;ORAL; EQ 37.5MG 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 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 091427 | AUROBINDO PHARMA USA |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212645 | CADILA PHARMS LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213485 | CSPC OUYI |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204744 | LANNETT CO INC |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204134 | LUPIN LTD |
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209293 | SCIECURE PHARMA INC |
| PAXIL CR | PAROXETINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020936 | APOTEX |