Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213286
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA 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 |
|---|---|---|---|---|---|---|---|
| 04/08/2020 | ORIG-1 | Approval | STANDARD |
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 PHARMS LTD |
| 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 LABS LTD |
| 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 | 075755 | MYLAN |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203836 | PAR FORM |
| 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 | 075872 | TEVA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211696 | UPSHER SMITH LABS |
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 PHARMS LTD |
| 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 LABS LTD |
| 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 | 075755 | MYLAN |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203836 | PAR FORM |
| 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 | 075872 | TEVA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211696 | UPSHER SMITH LABS |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English