Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209419
Company: PAR PHARM INC
Company: PAR PHARM INC
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 |
---|---|---|---|---|---|---|---|
11/16/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209419Orig1s000ltr.pdf |
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 | ALMATICA |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 213265 | AUROBINDO PHARMA LTD |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | TABLET;ORAL | Prescription | No | AB | 211721 | DR REDDYS |
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 |
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