Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204134
Company: LUPIN LTD
Company: LUPIN LTD
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 |
---|---|---|---|---|---|---|---|
01/20/2017 | ORIG-1 | Approval |
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 | 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 | 077873 | MYLAN |
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 TECHNOLOGIES |
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 | 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 | 077873 | MYLAN |
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 TECHNOLOGIES |
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 | 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 | 091427 | MYLAN |
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 TECHNOLOGIES |
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