Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214542
Company: GENUS

Products on ANDA 214542

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	30MG/ML	CONCENTRATE;ORAL	Prescription	AA	No	Yes
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML	CONCENTRATE;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214542

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214542Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214542

CHLORPROMAZINE HYDROCHLORIDE

CONCENTRATE;ORAL; 30MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	30MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	214542	GENUS
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	30MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	216678	RUBICON RESEARCH
SONAZINE	CHLORPROMAZINE HYDROCHLORIDE	30MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	080983	SAPTALIS PHARMS

CONCENTRATE;ORAL; 100MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	214542	GENUS
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	216678	RUBICON RESEARCH
SONAZINE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	080983	SAPTALIS PHARMS