Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077106
Company: ZYDUS
Company: ZYDUS
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-7 | Labeling-Package Insert |
Label is not available on this site. |
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02/21/2020 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/21/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/28/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/24/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/10/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
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08/23/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |