Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216678
Company: RUBICON RESEARCH

Products on ANDA 216678

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	No
CHLORPROMAZINE HYDROCHLORIDE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML	CONCENTRATE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216678

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216678

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