Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090027
Company: PRINSTON INC
Company: PRINSTON INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 25MG BASE | TABLET;ORAL | Discontinued | None | No | No |
VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 37.5MG BASE | TABLET;ORAL | Discontinued | None | No | No |
VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Discontinued | None | No | No |
VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Discontinued | None | No | No |
VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE 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 |
---|---|---|---|---|---|---|---|
08/04/2010 | 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 |
---|---|---|---|---|---|
08/18/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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09/21/2021 | SUPPL-15 | Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/14/2020 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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01/04/2017 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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07/17/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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07/26/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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10/16/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |