Application 208580

Type: ANDA
Sponsor: MYLAN LABS LTD

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
A208580-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS			2018-05-04

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	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)		2018-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)		2018-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)		2018-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)		2018-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)		2018-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)		2018-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2018-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	2018-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208580-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS		2018-05-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A208580-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208580-001	AP	1	`ea99ee380514…`

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 2 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	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
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Safecor Health LLC	5e1cbf26-d379-4315-8732-3939968f32c0	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
pantoprazole sodium	PANTOPRAZOLE SODIUM	Granules Pharmaceuticals Inc.	8f2fb647-15bc-41cb-84a4-02e956e614fc	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: pantoprazole sodium generic name: PANTOPRAZOLE SODIUM
Protonix I.V.	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	50802e19-72d3-4130-8d14-eb94361b38e7	2026-04-06	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE	Amneal Pharmaceuticals LLC	f3ded82a-cf0d-4844-944a-75f9f9215ff0	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	6b5ed424-2203-482f-bb85-2c97d9c356f2	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	PD-Rx Pharmaceuticals, Inc.	c1f37929-a981-4ace-95e6-ae6795a797b3	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Major Pharmaceuticals	9c286e5c-2b36-422b-9f74-e8c0abb3f747	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Aurobindo Pharma Limited	7418f358-f536-4de6-adf0-562b4373f2e3	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NorthStar Rx LLC	6637d90b-b268-4a5f-ab5b-885f2d5f0d4b	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Burel Pharmaceuticals, LLC	3cc5197e-6b39-4415-b963-d4bbeecd7953	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Torrent Pharmaceuticals Limited	9c983da1-a8e0-479e-8816-5d5668ea242e	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Camber Pharmaceuticals, Inc.	9daa1483-5a36-44db-9e0d-904d100da262	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	6229247e-ee15-466e-a8ac-adcd646b738d	2026-01-22	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Quallent Pharmaceuticals Health LLC	643eb498-d916-4fb7-9281-32895575ab36	2026-01-13	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.