Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076671
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | EQ 100MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/06/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/05/2024 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/13/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/21/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/25/2010 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 06/25/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/06/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/16/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/09/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/09/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |