Application 020406

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREVACID	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	Yes	No
002	PREVACID	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	30MG	Yes	Yes

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
N020406-001	PREVACID	LANSOPRAZOLE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10
N020406-002	PREVACID	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020406-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020406-001	PREVACID	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	1995-05-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020406-001	PREVACID	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD	1995-05-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020406-002	PREVACID	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	1995-05-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 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	N020406-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020406-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020406-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020406-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020406-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020406-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020406-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020406-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020406-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020406-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020406-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020406-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020406-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020406-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020406-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020406-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020406-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020406-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020406-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020406-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020406-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020406-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020406-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020406-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020406-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020406-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020406-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020406-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020406-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020406-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020406-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020406-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020406-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020406-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020406-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020406-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020406-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020406-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020406-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020406-002	AB	1	`a72a2bbeb626…`

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
Prevacid	LANSOPRAZOLE	Takeda Pharmaceuticals America, Inc.	71ba78cb-7e46-43eb-9425-fa130f537f84	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020406 application number: NDA020406 ndc (product): 64764-046

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-474	Lansoprazole	lansoprazole	Rebel Distributors Corp	NDA	Current
21695-652	Lansoprazole	lansoprazole	Rebel Distributors Corp	NDA	Current
49999-480	Prevacid	lansoprazole	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
55289-704	Prevacid	lansoprazole	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-704	Prevacid	lansoprazole	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-704	Prevacid	lansoprazole	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-704	Prevacid	lansoprazole	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-704	Prevacid	lansoprazole	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-704	Prevacid	lansoprazole	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-3352	Prevacid	lansoprazole	Bryant Ranch Prepack	NDA	Current
64764-046	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-046	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-046	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-046	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-046	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-046	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-046	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-541	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-541	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-541	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-541	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-541	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-541	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-541	Prevacid	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
70518-0502	Prevacid	lansoprazole	REMEDYREPACK INC.	NDA	Current
70518-0502	Prevacid	lansoprazole	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75041	SUPPL	2023-08-10
75040	SUPPL	2023-08-10
75022	SUPPL	2023-08-09
70478	SUPPL	2022-03-10
70463	SUPPL	2022-03-10
70409	SUPPL	2022-03-07
65413	SUPPL	2020-11-30
65412	SUPPL	2020-11-30
65374	SUPPL	2020-11-30
64586	SUPPL	2020-09-17
64567	SUPPL	2020-09-14
54575	SUPPL	2018-06-14
54574	SUPPL	2018-06-14
54514	SUPPL	2018-06-11
54513	SUPPL	2018-06-11
54512	SUPPL	2018-06-11
54511	SUPPL	2018-06-11
53707	SUPPL	2018-04-17
53696	SUPPL	2018-04-16
50182	SUPPL	2017-10-25
50100	SUPPL	2017-10-19
45714	SUPPL	2016-10-31
45664	SUPPL	2016-10-26
24930	SUPPL	2015-12-18
34620	SUPPL	2015-12-17
34621	SUPPL	2014-12-29
24931	SUPPL	2014-12-24
2497	SUPPL	2012-10-02
12550	SUPPL	2012-10-01
24929	SUPPL	2012-05-09
34619	SUPPL	2012-05-07
23580	ORIG	2011-12-20
41344	SUPPL	2011-12-09
12549	SUPPL	2011-11-01
24927	SUPPL	2011-10-31
34617	SUPPL	2011-06-07
2496	SUPPL	2011-06-03
34618	SUPPL	2011-05-26
24928	SUPPL	2011-05-25
12548	SUPPL	2010-09-10
2495	SUPPL	2010-09-09
34616	SUPPL	2010-05-17
2494	SUPPL	2010-05-17
41339	ORIG	2010-03-16
2493	SUPPL	2009-11-12
41351	SUPPL	2009-09-16
41350	SUPPL	2009-09-16
41346	SUPPL	2009-09-16
41345	SUPPL	2009-09-16
41342	SUPPL	2009-09-16
41341	SUPPL	2009-09-16
41340	SUPPL	2009-09-16
20648	SUPPL	2009-09-16
20647	SUPPL	2009-09-16
20646	SUPPL	2009-09-16
20644	SUPPL	2009-09-16
20643	SUPPL	2009-09-16
20642	SUPPL	2009-09-16
20639	SUPPL	2009-09-16
20638	SUPPL	2009-09-16
20637	SUPPL	2009-09-16
20636	SUPPL	2009-09-16
34615	SUPPL	2009-08-13
12547	SUPPL	2008-11-07
2492	SUPPL	2008-10-29
52963	SUPPL	2008-07-15
52962	SUPPL	2008-07-15
52961	SUPPL	2008-07-15
52960	SUPPL	2008-07-15
52305	SUPPL	2008-07-15
52304	SUPPL	2008-07-15
52303	SUPPL	2008-07-15
52302	SUPPL	2008-07-15
2491	SUPPL	2008-04-23
20649	SUPPL	2007-11-19
24926	SUPPL	2007-07-05
12546	SUPPL	2007-06-27
34614	SUPPL	2006-04-13
24925	SUPPL	2006-04-13
41352	SUPPL	2005-06-23
12545	SUPPL	2004-12-21
2490	SUPPL	2004-06-23
34613	SUPPL	2004-06-16
2489	SUPPL	2004-06-16
24924	SUPPL	2003-08-15
24920	SUPPL	2003-07-31
34611	SUPPL	2003-04-24
24923	SUPPL	2002-12-03
12544	SUPPL	2002-08-30
2488	SUPPL	2002-08-30
24922	SUPPL	2002-07-31
12543	SUPPL	2002-07-31
34612	SUPPL	2002-05-03
24921	SUPPL	2002-05-03
34610	SUPPL	2000-11-30
24919	SUPPL	2000-11-30
20645	SUPPL	2000-06-20
41348	SUPPL	1999-07-06
24918	SUPPL	1999-07-06
41349	SUPPL	1999-02-22