Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213873
Company: EUGIA PHARMA
Company: EUGIA PHARMA
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 |
---|---|---|---|---|---|---|---|
07/14/2022 | ORIG-1 | Approval | STANDARD |
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 | 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 | 212257 | SOMERSET THERAPS LLC |
PROCHLORPERAZINE EDISYLATE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 213626 | VIWIT PHARM |