Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076458
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 05/14/2004 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076458_S000_FLUOXETINETOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2021 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/18/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/14/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/02/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 08/02/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/15/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |