Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040185
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG 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 |
|---|---|---|---|---|---|---|---|
| 10/28/1996 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/22/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/19/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/29/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/22/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/13/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/09/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |