Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077395
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 12/04/2006 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/077395.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/17/2020 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/07/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/07/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/15/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/09/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/09/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |