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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215074
Company: DEVA HOLDING AS

Products on ANDA 215074

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215074

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 215074

PANTOPRAZOLE SODIUM

INJECTABLE;INTRAVENOUS; EQ 40MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	219230	ALEMBIC
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	213778	ASPIRO
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	216171	BE PHARMS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215074	DEVA HOLDING AS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	079197	EPIC PHARMA LLC
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	205675	EUGIA PHARMA
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	204400	GLAND
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	209524	HANGZHOU ZHONGMEI
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	214680	KNACK
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215860	MEITHEAL
PROTONIX IV	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	020988	WYETH PHARMS

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