Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040268
Company: JUBILANT CADISTA
Company: JUBILANT CADISTA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCOMP | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| PROCOMP | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/27/1998 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40268ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2025 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/040268Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/040268Orig1s033ltr.pdf | |
| 02/23/2017 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/15/2009 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/30/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/14/2010 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/18/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/03/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/07/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/20/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/22/2025 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/040268Orig1s033lbl.pdf |
PROCOMP
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 | 218515 | AJANTA PHARMA LTD |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 216598 | AMNEAL |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 218734 | AUROBINDO PHARMA LTD |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 217478 | BIONPHARMA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 217847 | DR REDDYS LABS SA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 216595 | GLENMARK PHARMS LTD |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 218912 | LEADING |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 216202 | NOVITIUM PHARMA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 216495 | ZYDUS LIFESCIENCES |
| PROCOMP | PROCHLORPERAZINE MALEATE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 040268 | JUBILANT CADISTA |
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 | 218515 | AJANTA PHARMA LTD |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216598 | AMNEAL |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 218734 | AUROBINDO PHARMA LTD |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 217478 | BIONPHARMA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 217847 | DR REDDYS LABS SA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216595 | GLENMARK PHARMS LTD |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 218912 | LEADING |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216202 | NOVITIUM PHARMA |
| PROCHLORPERAZINE MALEATE | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216495 | ZYDUS LIFESCIENCES |
| PROCOMP | PROCHLORPERAZINE MALEATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 040268 | JUBILANT CADISTA |