Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078677
Company: REYOUNG
Company: REYOUNG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | AB | No | No |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | AB | No | No |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG 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 |
---|---|---|---|---|---|---|---|
03/04/2009 | ORIG-1 | Approval |
Label is not available on this site. |
SERTRALINE HYDROCHLORIDE
TABLET;ORAL; EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 202825 | ACCORD HLTHCARE |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076881 | ACI |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 214790 | ASCENT PHARMS INC |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077206 | AUROBINDO PHARMA |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078403 | GRANULES |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076465 | HERITAGE PHARMA AVET |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077397 | INVAGEN PHARMS |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 077670 | LUPIN |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078175 | OXFORD PHARMS |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 078677 | REYOUNG |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076442 | SCIEGEN PHARMS INC |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | No | AB | 076882 | VIWIT PHARM |
ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019839 | VIATRIS |
TABLET;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 202825 | ACCORD HLTHCARE |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076881 | ACI |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 214790 | ASCENT PHARMS INC |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077206 | AUROBINDO PHARMA |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078403 | GRANULES |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076465 | HERITAGE PHARMA AVET |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077397 | INVAGEN PHARMS |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 077670 | LUPIN |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078175 | OXFORD PHARMS |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 078677 | REYOUNG |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076442 | SCIEGEN PHARMS INC |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 076882 | VIWIT PHARM |
ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019839 | VIATRIS |
TABLET;ORAL; EQ 100MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 202825 | ACCORD HLTHCARE |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076881 | ACI |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 214790 | ASCENT PHARMS INC |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077206 | AUROBINDO PHARMA |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078403 | GRANULES |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076465 | HERITAGE PHARMA AVET |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077397 | INVAGEN PHARMS |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 077670 | LUPIN |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078175 | OXFORD PHARMS |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 078677 | REYOUNG |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076442 | SCIEGEN PHARMS INC |
SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 076882 | VIWIT PHARM |
ZOLOFT | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019839 | VIATRIS |