Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040540
Company: SAGENT
Company: SAGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
05/28/2004 | 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 |
---|---|---|---|---|---|
03/11/2019 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
08/17/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/12/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
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09/03/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/25/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
PROCHLORPERAZINE EDISYLATE
INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214192 | AMNEAL |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204147 | AVET LIFESCIENCES |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214379 | CAPLIN |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213873 | EUGIA PHARMA |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 214107 | GLAND PHARMA LTD |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 089903 | HIKMA |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213630 | HIKMA |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210710 | MYLAN LABS LTD |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204860 | NEXUS |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 040540 | SAGENT |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213626 | VIWIT PHARM |