Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075207
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG 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 |
|---|---|---|---|---|---|---|---|
| 01/30/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75207ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/29/2019 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2011 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/10/2009 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 07/09/2009 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 02/11/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/11/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/22/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/22/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 05/25/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/25/2007 | SUPPL-9 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 08/17/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/31/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/22/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/22/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/13/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/14/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |