Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077765
Company: TORRENT PHARMS
Company: TORRENT PHARMS
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 |
---|---|---|---|---|---|
02/21/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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12/17/2015 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/17/2015 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/24/2012 | SUPPL-13 | Labeling-Medication Guide |
Label is not available on this site. |
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11/14/2011 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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04/26/2010 | SUPPL-9 | Labeling-Medication Guide |
Label is not available on this site. |
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05/28/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
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05/28/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/14/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
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02/14/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |