Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076001
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | AB1 | No | No |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 01/29/2002 | 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 |
|---|---|---|---|---|---|
| 12/23/2020 | SUPPL-48 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/23/2020 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/23/2020 | SUPPL-43 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-39 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/17/2014 | SUPPL-36 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/17/2014 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/10/2016 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/19/2010 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/28/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 08/18/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/18/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 01/16/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/24/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/28/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/22/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/22/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/22/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/26/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 090223 | ALEMBIC PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075049 | APNAR PHARMA LP |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 078619 | AUROBINDO PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 206993 | CADILA PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 201336 | HERITAGE PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075245 | IVAX SUB TEVA PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075464 | LANDELA PHARM |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075465 | MARKSANS PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 216232 | MICRO LABS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 204597 | SCIEGEN PHARMS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075452 | TEVA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 076001 | TEVA PHARMS USA |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | Yes | AB1 | 018936 | ELI LILLY AND CO |
CAPSULE;ORAL; EQ 20MG BASE
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 090223 | ALEMBIC PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075049 | APNAR PHARMA LP |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 078619 | AUROBINDO PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 206993 | CADILA PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 201336 | HERITAGE PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075245 | IVAX SUB TEVA PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075464 | LANDELA PHARM |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075465 | MARKSANS PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 216232 | MICRO LABS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 204597 | SCIEGEN PHARMS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 075452 | TEVA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | No | AB1 | 076001 | TEVA PHARMS USA |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Prescription | Yes | AB1 | 018936 | ELI LILLY AND CO |