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 6 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	A-S Medication Solutions	3a8fa326-ad75-4b6d-8832-0a2357eeca2f	2024-04-25	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	3e5421ef-0875-4a04-b17d-95cca0052c83	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Bryant Ranch Prepack	617bb464-5357-472f-8e9d-61aae5b2ebef	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Golden State Medical Supply, Inc.	d6aae78e-308b-7072-e053-2a95a90aaa10	2024-03-29	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Asclemed USA, Inc.	3540d01c-da0e-477e-9e90-994b96deb1d6	2024-03-13	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Asclemed USA, Inc.	ff15c4f1-8869-4422-9631-dc488e09e583	2024-02-14	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	Baxter Healthcare Company	a476e063-9450-4793-9a22-16b0a0a61cd0	2024-02-14	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	A-S Medication Solutions	517d6b02-0e68-4d6b-98b3-eac0be457e6b	2023-12-16	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Camber Pharmaceuticals, Inc.	ee6278c0-d8c0-417c-a65c-b522ff76fe44	2023-11-02	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Mylan Pharmaceuticals Inc.	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	2023-08-15	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Sagent Pharmaceuticals	c39be14b-e881-4586-b77e-4747db494954	2023-08-14	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	Sun Pharmaceutical Industries, Inc.	38353b9e-63bd-47e8-b7cb-b198d1e901f9	2023-08-03	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	A-S Medication Solutions	f1eb666a-120d-47fd-8c9f-73cef839294a	2023-07-31	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Lannett Company, Inc.	e7705bf6-e473-4b9c-bb5d-57e26ffe7b97	2023-07-21	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Hikma Pharmaceuticals USA Inc.	1e102c44-232b-4aaf-b457-2a740c47193a	2023-07-19	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Hikma Pharmaceuticals USA Inc.	b02f3f85-8f9b-4d06-8eae-73e592626f3e	2023-07-10	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	c10e9c12-e39d-4b0b-bd4c-10d3e9a4cf34	2023-02-17	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	XLCare Pharmaceuticals Inc.	17468dbf-84b6-4c53-9ad5-341350d2cfab	2023-01-17	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	e3f711d8-b9d3-46a6-8bf9-6af1cc77003e	2022-07-15	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Proficient Rx LP	a03aa46f-9eb5-4cf4-addf-745d94af8261	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium 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