Application 090296

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	INJECTABLE;IV (INFUSION)	EQ 40MG BASE/VIAL	No	No

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
A090296-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS			2015-07-14

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2015-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2015-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090296-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2015-07-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090296-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090296-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090296-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090296-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090296-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090296-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090296-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090296-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090296-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090296-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090296-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090296-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090296-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090296-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090296-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090296-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090296-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090296-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090296-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090296-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090296-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090296-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090296-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090296-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090296-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090296-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090296-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090296-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090296-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090296-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090296-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090296-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090296-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090296-001	AP	1	`cb3db0bc1861…`

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 7 · 122 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Edenbridge Pharmaceuticals LLC.	a0bb76bc-094a-4d61-9bb2-2226c9da4ae9	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	76e1839b-7462-4344-b319-001a5f57d67a	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Eugia US LLC	9bed093a-9586-4c82-a2b7-c68f89d0faef	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	f38a6df2-1dd4-48bf-9ec4-1113ce492e78	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Unit Dose Solutions, Inc.	558dc7e1-dfd5-d3d7-e063-6394a90ab9c3	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	f313159c-115a-4cf6-b32e-9ddc833fd51c	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Sportpharm LLC	b58c376e-616b-4970-a375-52ff630e7f09	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Unit Dose Solutions, Inc.	5566b4b1-b4f5-4020-e063-6394a90a5257	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	HAWAII REPACK, INC.	f85e6d64-1ddc-4f4a-86dc-0749081a6a5f	2026-06-27	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	HAWAII REPACK, INC.	f403c94d-68b7-43df-8c8e-c9fef3309cfc	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	St. Mary's Medical Park Pharmacy	e1aa55ec-5e0e-3a58-e053-2a95a90abe4f	2026-06-21	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	03dea010-4bae-43ab-893e-9bbddb58062d	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Coupler LLC	5331f534-4724-52e8-e063-6394a90aa548	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Coupler LLC	52bbab54-9f11-77bc-e063-6394a90ab449	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole sodium	PANTOPRAZOLE SODIUM	Gland Pharma Limited	c1ad8f91-3783-4139-8154-e461a53809c1	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	9a1159d3-b9fa-4026-962c-d3001002e610	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Protonix Delayed-Release	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	08098cb2-c048-4640-f387-6beec4a38936	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Bryant Ranch Prepack	fa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	QPharma Inc	0e200326-8885-18d0-e063-6294a90aad2f	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northstar Rx LLC	7e0c5dac-6832-4692-b012-ca59d5e88987	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM

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
0480-4111	Pantoprazole Sodium	Pantoprazole Sodium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0781-3232	Pantoprazole Sodium	Pantoprazole Sodium	Sandoz Inc	ANDA	Current
0781-3232	Pantoprazole Sodium	Pantoprazole Sodium	Sandoz Inc	ANDA	Current
0781-3232	Pantoprazole Sodium	Pantoprazole Sodium	Sandoz Inc	ANDA	Current
0781-3232	Pantoprazole Sodium	Pantoprazole Sodium	Sandoz Inc	ANDA	Current
65219-433	Pantoprazole Sodium	Pantoprazole Sodium	Fresenius Kabi USA, LLC	ANDA	Current
72572-550	Pantoprazole Sodium	Pantoprazole Sodium	Civica, Inc.	ANDA	Current
72572-550	Pantoprazole Sodium	Pantoprazole Sodium	Civica, Inc.	ANDA	Current
72572-550	Pantoprazole Sodium	Pantoprazole Sodium	Civica, Inc.	ANDA	Current