Application 090901

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 20MG BASE	No	No
002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	EQ 40MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090901-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2011-08-30
A090901-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL			2011-08-30

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 3 · 86 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	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2011-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090901-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-08-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090901-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-08-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090901-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090901-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090901-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090901-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090901-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090901-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090901-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090901-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090901-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090901-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090901-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090901-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090901-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090901-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090901-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090901-002	AB	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 3 of 7 · 123 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Quallent Pharmaceuticals Health LLC	643eb498-d916-4fb7-9281-32895575ab36	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	AvPAK	dcac4022-fea1-67c5-3331-fefcc3c440d8	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Major Pharmaceuticals	de419aa0-caa9-40fb-bc6d-e341c94273c7	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Northwind Health Company, LLC	da67e1c0-9947-957d-e053-2a95a90ad96d	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northwind Health Company, LLC	f2a1af50-a051-3e55-e053-2a95a90a9184	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northwind Health Company, LLC	d9deb251-96d3-5f96-e053-2a95a90a0792	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	410d5577-e50a-44f3-aaa8-fbf391a0c261	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Chartwell RX, LLC	42a969c3-1144-4151-9cf3-3e9bace6a380	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Protonix I.V.	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	51e4144a-489e-436c-609a-39305f8f56ba	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Protonix I.V.	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	f39b3e7d-39d2-4c8a-9974-4ab885241880	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	QPharma Inc	b4a94a37-47c1-4dd9-9e4d-5b4a03480aa6	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	AvPAK	b9fa8381-b75e-b1cd-e053-2a95a90a9883	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	QPharma Inc	fbd035d0-529c-6033-e053-6294a90abf07	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole sodium	PANTOPRAZOLE SODIUM	Ajanta Pharma USA Inc.	90963a38-f629-45a4-bddd-9e13a55fe0f7	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE	PHOENIX RX LLC	440b9ae8-2fb8-5d35-e063-6294a90a82b6	2025-11-20	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	4ba4c797-3f97-4d85-971e-7b17bdf89221	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	362229c5-7b28-4563-aa62-d97d06005480	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
PANTOPRAZOLE SODIUM I.V.	PANTOPRAZOLE SODIUM	Piramal Critical Care	0696b10c-972b-9dcf-e063-6294a90a1034	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	PD-Rx Pharmaceuticals, Inc.	b422c5eb-9a6d-4f8c-863d-ca515ec780c2	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Pantoprazole Sodium generic name: PANTOPRAZOLE SODIUM
Pantoprazole Sodium	PANTOPRAZOLE	Bryant Ranch Prepack	d212e8ec-f7ff-4727-a83e-0edc4ca7e6d1	2025-09-26	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-283	Pantoprazole Sodium	Pantoprazole Sodium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-283	Pantoprazole Sodium	Pantoprazole Sodium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-284	Pantoprazole Sodium	Pantoprazole Sodium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-284	Pantoprazole Sodium	Pantoprazole Sodium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-284	Pantoprazole Sodium	Pantoprazole Sodium	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
61919-635	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	DIRECT RX	ANDA	Current
68788-9660	Pantoprazole Sodium	Pantoprazole Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current