Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212257
Company: SOMERSET THERAPS LLC

Products on ANDA 212257

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2026	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212257

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	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
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	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