Application 020987

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020987-001	PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02
N020987-002	PROTONIX	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020987-001	AB
N020987-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020987-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020987-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020987-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020987-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020987-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020987-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020987-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020987-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020987-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020987-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020987-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020987-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020987-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020987-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020987-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020987-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020987-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020987-002	AB	1	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Protonix Delayed-Release	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	08098cb2-c048-4640-f387-6beec4a38936	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020987 application number: NDA020987 ndc (product): 0008-0843 ndc (product): 0008-0841

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0008-0841	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0841	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0841	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0841	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0843	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0843	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0843	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-0843	Protonix	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
21695-108	Protonix	pantoprazoel sodium	Rebel Distributors Corp	NDA	Current
43353-338	Pantoprazole Sodium	pantoprazole sodium	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
63187-005	Pantoprazole Sodium	pantoprazole sodium	Proficient Rx	NDA	Current
67046-535	Pantoprazole Sodium	pantoprazole sodium	Contract Pharmacy Services-PA	NDA	Current
67296-0029	Protonix	PANTOPRAZOLE SODIUM	RedPharm Drug, Inc.	NDA	Current
69189-0841	Protonix	PANTOPRAZOLE SODIUM	Avera McKennan Hospital	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74812	SUPPL	2023-07-20
74811	SUPPL	2023-07-20
74793	SUPPL	2023-07-19
70448	SUPPL	2022-03-09
70445	SUPPL	2022-03-09
70421	SUPPL	2022-03-07
65417	SUPPL	2020-11-30
65416	SUPPL	2020-11-30
65377	SUPPL	2020-11-30
60233	SUPPL	2019-10-04
60227	SUPPL	2019-10-04
58448	SUPPL	2019-04-26
58445	SUPPL	2019-04-26
58436	SUPPL	2019-04-26
54571	SUPPL	2018-06-14
54504	SUPPL	2018-06-11
50876	SUPPL	2017-12-27
50838	SUPPL	2017-12-22
48957	SUPPL	2017-07-12
48949	SUPPL	2017-07-11
48940	SUPPL	2017-07-10
45718	SUPPL	2016-10-31
45658	SUPPL	2016-10-26
14103	SUPPL	2014-12-29
3968	SUPPL	2014-12-24
26396	SUPPL	2013-12-13
35812	SUPPL	2013-12-11
14102	SUPPL	2012-10-15
26395	SUPPL	2012-10-11
35811	SUPPL	2012-05-15
23614	ORIG	2011-12-20
14101	SUPPL	2011-11-01
3966	SUPPL	2011-10-31
35810	SUPPL	2011-05-25
3967	SUPPL	2011-05-25
14100	SUPPL	2010-09-10
3965	SUPPL	2010-09-08
26394	SUPPL	2009-11-25
3964	SUPPL	2009-11-25
35809	SUPPL	2009-11-16
14099	SUPPL	2009-11-16
3963	SUPPL	2008-01-09
26393	SUPPL	2006-07-27
26392	SUPPL	2004-12-02
35807	SUPPL	2004-05-07
3960	SUPPL	2004-05-07
35808	SUPPL	2004-04-05
14097	SUPPL	2004-04-05
26391	SUPPL	2004-03-16
26390	SUPPL	2004-03-10
14098	SUPPL	2004-01-15
3962	SUPPL	2004-01-14
3961	SUPPL	2004-01-14
35805	SUPPL	2003-04-25
35804	SUPPL	2003-04-09
3959	SUPPL	2002-10-28
35806	SUPPL	2002-04-19
21331	SUPPL	2002-04-19
3958	SUPPL	2002-04-19
26389	SUPPL	2001-06-12
3957	SUPPL	2001-06-12
41862	ORIG	2000-02-02
14096	ORIG	2000-02-02
3956	ORIG	2000-02-02