Drugs@FDA: FDA-Approved Drugs
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
08/02/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74803ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074803_fluoxetine_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/24/2010 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
07/14/2009 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
09/25/2008 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
03/17/2008 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
03/17/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
08/25/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
08/25/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
11/26/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
11/26/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/30/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf |
01/30/2002 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf |
01/30/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf |
01/30/2002 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf |
01/30/2002 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf |
01/30/2002 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf |
12/13/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/13/2001 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
12/13/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/02/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pdf |