Drugs@FDA: FDA-Approved Drugs
Company: WOCKHARDT BIO AG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
08/29/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/04/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
12/27/2016 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/23/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
05/06/2010 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/21/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
06/03/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/03/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
10/10/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
05/09/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/02/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/31/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
FLUOXETINE HYDROCHLORIDE
SOLUTION;ORAL; EQ 20MG BASE/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 079209 | AUROBINDO PHARMA LTD |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 077849 | LANNETT CO INC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 076015 | PHARM ASSOC |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 075506 | TEVA |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 075514 | WOCKHARDT BIO AG |
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