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 |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English