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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205675
Company: EUGIA PHARMA

Products on ANDA 205675

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 205675

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2016	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
03/05/2024	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
08/02/2023	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
07/28/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
03/19/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/20/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/17/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/17/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/17/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/17/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/17/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205675

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	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	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 PHARMA LTD
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
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090296	SANDOZ
PROTONIX IV	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	020988	WYETH PHARMS

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