Drugs@FDA: FDA-Approved Drugs
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 | Prescription | AB | No | No |
PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | 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. |
||
07/22/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
11/19/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
05/29/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
06/22/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
12/13/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/09/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
02/05/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROCHLORPERAZINE MALEATE
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 040185 | MYLAN |
PROCOMP | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 040268 | JUBILANT CADISTA |
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 040185 | MYLAN |
PROCOMP | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 040268 | JUBILANT CADISTA |
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