Application 209463

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	POWDER;IV (INFUSION)	EQ 40MG BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209463-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N209463-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2017-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)		RLD, RS	2017-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)		RLD, RS	2017-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)		RLD, RS	2017-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)		RLD, RS	2017-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)		RLD, RS	2017-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)		RLD, RS	2017-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)			2017-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / IV (INFUSION)			2017-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209463-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-06-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209463-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209463-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209463-001	AP	1	`6a471c1ec25d…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209463-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209463-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209463-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209463-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209463-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209463-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209463-001	AP	1	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209463-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	362229c5-7b28-4563-aa62-d97d06005480	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209463 application number: NDA209463 ndc (product): 55154-7477
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Civica, Inc.	c857dc41-7b47-4f26-a9f5-d76eb82b44ee	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209463 application number: NDA209463
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Hikma Pharmaceuticals USA Inc.	1e102c44-232b-4aaf-b457-2a740c47193a	2023-07-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209463 application number: NDA209463 ndc (product): 0143-9300
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Hikma Pharmaceuticals USA Inc.	b02f3f85-8f9b-4d06-8eae-73e592626f3e	2023-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209463 application number: NDA209463 ndc (product): 0143-9284

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9284	Pantoprazole Sodium	Pantoprazole Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9284	Pantoprazole Sodium	Pantoprazole Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9284	Pantoprazole Sodium	Pantoprazole Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9284	Pantoprazole Sodium	Pantoprazole Sodium	West-Ward Pharmaceuticals Corp	NDA	Current
0143-9300	Pantoprazole Sodium	Pantoprazole Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9300	Pantoprazole Sodium	Pantoprazole Sodium	Hikma Pharmaceuticals USA Inc.	NDA	Current
0143-9300	Pantoprazole Sodium	Pantoprazole Sodium	West-Ward Pharmaceuticals Corp	NDA	Current
55154-7477	Pantoprazole Sodium	Pantoprazole Sodium	Cardinal Health	NDA	Current
55154-7477	Pantoprazole Sodium	Pantoprazole Sodium	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74827	SUPPL	2023-07-20
74784	SUPPL	2023-07-19
70455	SUPPL	2022-03-10
70433	SUPPL	2022-03-07
69813	SUPPL	2022-01-05
65436	SUPPL	2020-12-01
65364	SUPPL	2020-11-30
63691	SUPPL	2020-06-24
63680	SUPPL	2020-06-24
55940	SUPPL	2018-10-15
55939	SUPPL	2018-10-15
55895	SUPPL	2018-10-11
52678	ORIG	2018-02-21
48906	ORIG	2017-07-05
48894	ORIG	2017-07-03