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 5 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f5c9e3c6-d4b0-0ebe-e053-2995a90abe55	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Fresenius Kabi USA, LLC	340b57c2-bcf8-4f46-b522-886daaf80351	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Quality Care Products, LLC	a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Civica, Inc.	c857dc41-7b47-4f26-a9f5-d76eb82b44ee	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	NuCare Pharmaceuticals,Inc.	a9f32edf-e0b9-4e96-e053-2a95a90afbc8	2024-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole sodium	PANTOPRAZOLE SODIUM	American Health Packaging	423dac8b-bb1e-4456-9b6e-913c028b11bc	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	6faf465b-c3a3-4ae7-9e16-1ba758f6962a	2024-09-19	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	NorthStar RxLLC	4494f9d0-a1c8-477f-9b4a-f65d7637d9ec	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	NuCare Pharmaceuticals,Inc.	b2abc159-e450-99dc-e053-2a95a90abe6a	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals, Inc.	4fbec80c-b38d-122c-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Proficient Rx LP	50a278de-bd16-417c-a741-81bfe0d745f2	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	1c46140c-2399-5ca3-e063-6394a90af33b	2024-06-27	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	924a80b9-de48-90c0-e053-2995a90a00e1	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	NuCare Pharmaceuticals,Inc.	8748a588-a1e5-9dfc-e053-2a95a90a846c	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	88f408cf-1b3e-4d7a-e053-2a95a90a369f	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	1680b4ed-d5b0-4fd9-b1d1-04df6a2138be	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	7d51104d-b135-421f-8425-03b5772e7103	2024-05-20	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Asclemed USA, Inc.	138b30cb-6b28-450e-9e7a-42576cc76545	2024-05-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	A-S Medication Solutions	485212d4-caee-4a55-8299-87a28d6bd8f0	2024-04-29	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	A-S Medication Solutions	39ba58cc-e4ef-4b82-a0f3-9583fa123a38	2024-04-25	Warnings, Adverse reactions	Name fallback brand 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