Application 079197

Type: ANDA
Sponsor: AKORN 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 43.

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
A079197-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2012-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079197-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2012-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079197-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2012-11-08	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A079197-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079197-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079197-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079197-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079197-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079197-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079197-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079197-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079197-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079197-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079197-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079197-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079197-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079197-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079197-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079197-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079197-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079197-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079197-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079197-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079197-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079197-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079197-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079197-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079197-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079197-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079197-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079197-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079197-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079197-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079197-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079197-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079197-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079197-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079197-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079197-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079197-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079197-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079197-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079197-001	AP	1	`f41ea6bd6efb…`

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 4 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Devatis Inc.	13c337e7-1e7b-47bd-9f88-92b0d548ca9c	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Mylan Institutional Inc.	a9b0d279-118b-4372-bd51-d4bad9c1cfca	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Meitheal Pharmaceuticals Inc.	014f9762-6948-46b7-8659-5c89f35ad8bf	2025-06-27	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Aphena Pharma Solutions - Tennessee, LLC	c9bc288b-e84c-4e31-a769-c87a59226086	2025-06-09	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Protonix I.V.	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b	2025-04-22	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM INJECTION	Alembic Pharmaceuticals Limited	02ee7ed6-217f-4128-bbbb-b9390475a65b	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM INJECTION	Alembic Pharmaceuticals Inc.	a9e5fac6-2db6-4311-a98b-eb3f0dde19d6	2025-04-07	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	Rising Pharma Holdings, Inc.	91a6b13f-457f-4136-9541-c4adb9c3c35c	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	Aurobindo Pharma Limited	b3cec41e-e98b-470a-8ba2-c31537023989	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM generic name: PANTOPRAZOLE SODIUM
Pantoprazole sodium	PANTOPRAZOLE SODIUM	Sun Pharmaceutical Industries Limited	eb3f58d4-0c69-4377-be45-c36099c98d33	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	A-S Medication Solutions	81696241-17d5-4d35-9e59-8c28469ffd2c	2025-03-14	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Meitheal Pharmaceuticals Inc.	c18aff31-f91e-4b6a-9713-52c9094c6082	2025-03-13	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole sodium	PANTOPRAZOLE SODIUM	BE Pharmaceuticals Inc.	52d5bc28-66df-43aa-bb1a-8ac4a2a7f693	2025-03-07	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	8aac1642-6cb0-6ad2-e053-2a95a90a4cbd	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	Sun Pharmaceutical Industries, Inc.	d9fcf6a2-3788-4955-84d9-3c319b13267c	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	DIRECT RX	a7e7c1ab-3e75-1ff8-e053-2995a90a7539	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	b3277cb8-26d0-bce0-e053-2a95a90af6dd	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	c89a5396-1d94-c7fa-e053-2995a90a9063	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	bd4759ac-46b5-6903-e053-2a95a90a6319	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	d27e1fdd-e23f-0d60-e053-2a95a90a9087	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43158	ORIG	2013-01-22