Drugs@FDA: FDA Approved Drug Products
Company: ACP NIMBLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCHLORPERAZINE | PROCHLORPERAZINE | 25MG | SUPPOSITORY;RECTAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/24/1993 | 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-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/21/2011 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/11/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/03/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/18/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PROCHLORPERAZINE
SUPPOSITORY;RECTAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COMPRO | PROCHLORPERAZINE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040246 | PADDOCK LLC |
| PROCHLORPERAZINE | PROCHLORPERAZINE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040058 | ACP NIMBLE |
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