Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211653
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG 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 |
---|---|---|---|---|---|---|---|
04/15/2019 | 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 |
---|---|---|---|---|---|
08/18/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
09/20/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
FLUOXETINE 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 |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 208698 | ALEMBIC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 213286 | AUROBINDO PHARMA LTD |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076006 | DR REDDYS |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203836 | ENDO OPERATIONS |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211653 | LUPIN LTD |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 210935 | SCIEGEN PHARMS INC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 212684 | STRIDES PHARMA |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 208698 | ALEMBIC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 213286 | AUROBINDO PHARMA LTD |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 076006 | DR REDDYS |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203836 | ENDO OPERATIONS |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211653 | LUPIN LTD |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 210935 | SCIEGEN PHARMS INC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 212684 | STRIDES PHARMA |