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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209463
Company: HIKMA

Products on NDA 209463

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209463

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209463s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209463Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209463Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209463s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209463Orig1s021ltr.pdf
03/04/2022	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209463s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209463Orig1s015ltr.pdf
07/26/2021	SUPPL-13	Manufacturing (CMC)-Manufacturing Process	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209463Orig1s013ltr.pdf
11/27/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209463Orig1s011ltr.pdf
06/23/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209463Orig1s006ltr.pdf
10/10/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209463s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209463Orig1s005Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209463Orig1s005Ltr.pdf

Labels for NDA 209463

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209463s021lbl.pdf
03/04/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209463s015lbl.pdf
11/27/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s011lbl.pdf
06/23/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209463s006lbl.pdf
10/10/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209463s005lbl.pdf
06/30/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209463s000lbl.pdf

Therapeutic Equivalents for NDA 209463

PANTOPRAZOLE SODIUM

POWDER;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	POWDER;INTRAVENOUS	Prescription	No	AP	216021	FRESENIUS KABI USA
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription	Yes	AP	209463	HIKMA

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