Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211816
Company: EUGIA PHARMA
Company: EUGIA PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/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 |
---|---|---|---|---|---|---|---|
07/07/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CHLORPROMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION; 25MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 080365 | DR REDDYS |
CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211816 | EUGIA PHARMA |
CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 083329 | HIKMA |
CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217275 | ZYDUS PHARMS |