Application 205119

Type: ANDA
Sponsor: AMNEAL PHARMS

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 42.

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
A205119-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2016-01-26
A205119-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2016-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205119-001	AB
A205119-002	AB

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 · 84 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
2026-08-18 06:07:40	2026-07	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205119-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205119-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205119-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205119-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205119-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205119-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205119-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205119-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205119-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205119-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205119-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205119-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205119-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205119-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205119-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205119-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205119-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205119-002	AB	1	`bb7c543d1eb4…`

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE	Amneal Pharmaceuticals LLC	f3ded82a-cf0d-4844-944a-75f9f9215ff0	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119 ndc (product): 65162-637 ndc (product): 65162-636
Pantoprazole Sodium	PANTOPRAZOLE	PHOENIX RX LLC	440b9ae8-2fb8-5d35-e063-6294a90a82b6	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119
Pantoprazole Sodium	PANTOPRAZOLE	Bryant Ranch Prepack	d212e8ec-f7ff-4727-a83e-0edc4ca7e6d1	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119 ndc (product): 71335-0291
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	b3277cb8-26d0-bce0-e053-2a95a90af6dd	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119 ndc (product): 80425-0085
Pantoprazole Sodium	PANTOPRAZOLE	Proficient Rx LP	a7dc4321-331d-49af-976c-cfd69d0055d9	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119 ndc (product): 63187-837
Pantoprazole Sodium	PANTOPRAZOLE	Proficient Rx LP	6d03491f-20c6-4878-9741-2e21e221eff2	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119 ndc (product): 63187-974

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43353-569	Pantoprazole Sodium	Pantoprazole	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
45865-676	Pantoprazole Sodium	Pantoprazole	medsource pharmaceuticals	ANDA	Current
63187-837	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
63187-837	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
63187-837	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
63187-837	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
63187-837	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
63187-837	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
63187-974	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
63187-974	Pantoprazole Sodium	Pantoprazole	Proficient Rx LP	ANDA	Current
65162-636	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-636	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-636	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-636	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-636	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-636	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-636	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-637	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-637	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-637	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-637	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-637	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-637	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
65162-637	Pantoprazole Sodium	Pantoprazole	Amneal Pharmaceuticals LLC	ANDA	Current
70332-300	PANTOPRAZOLE SODIUM	PANTOPRAZOLE	California Pharmaceuticals LLC	ANDA	Current
71335-0291	Pantoprazole Sodium	Pantoprazole	Bryant Ranch Prepack	ANDA	Current
71335-0291	Pantoprazole Sodium	Pantoprazole	Bryant Ranch Prepack	ANDA	Current
71335-0291	Pantoprazole Sodium	Pantoprazole	Bryant Ranch Prepack	ANDA	Current
71335-0291	Pantoprazole Sodium	Pantoprazole	Bryant Ranch Prepack	ANDA	Current
80425-0085	Protonix	Pantoprazole 20mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0085	Pantoprazole Sodium	Pantoprazole Sodium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0085	Pantoprazole Sodium	Pantoprazole Sodium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0085	Pantoprazole Sodium	Pantoprazole Sodium	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current