Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075577
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| 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 |
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/2001/75577TA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/08/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/17/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/12/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/12/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/28/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 05/17/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 05/17/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |