Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211632
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 60MG 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 |
|---|---|---|---|---|---|---|---|
| 02/08/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUOXETINE HYDROCHLORIDE
TABLET;ORAL; EQ 60MG 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 60MG BASE | TABLET;ORAL | Prescription | Yes | AB | 202133 | ALVOGEN |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 211721 | DR REDDYS LABS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 212191 | G AND W LABS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 209695 | INVENTIA HLTHCARE |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 211632 | LUPIN LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 209419 | PAR PHARM INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 211282 | SCIEGEN PHARMS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 211477 | TARO |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 211051 | TEVA PHARMS USA |
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