Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075452
Company: TEVA
Company: TEVA
| 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 |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/29/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75452ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/19/2021 | SUPPL-44 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2021 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2021 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/24/2010 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2009 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/22/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/11/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/17/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 08/02/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/02/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/17/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/31/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/31/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/13/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/26/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-1 | Manufacturing (CMC)-Manufacturing Process |
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 |
CAPSULE;ORAL; EQ 40MG 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 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090223 | ALEMBIC PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075049 | APNAR PHARMA LP |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 078619 | AUROBINDO PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 206993 | CADILA PHARMS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 201336 | HERITAGE PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075245 | IVAX SUB TEVA PHARMS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075465 | MARKSANS PHARMA |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 216232 | MICRO LABS |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 204597 | SCIEGEN PHARMS INC |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 076990 | SUN PHARM INDS LTD |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075452 | TEVA |
| PROZAC | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 018936 | ELI LILLY AND CO |