Application 021428

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREVACID	LANSOPRAZOLE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	15MG	Yes	No
002	PREVACID	LANSOPRAZOLE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	30MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021428-001	PREVACID	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD	2002-08-30
N021428-002	PREVACID	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD, RS	2002-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021428-001	AB
N021428-002	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 3 of 3 · 88 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
2022-10-28 04:53 UTC	2022-10	N021428-001	PREVACID	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD	2002-08-30	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021428-002	PREVACID	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD, RS	2002-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021428-001	PREVACID	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD	2002-08-30	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021428-002	PREVACID	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD, RS	2002-08-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021428-001	PREVACID	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD	2002-08-30	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021428-002	PREVACID	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD, RS	2002-08-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021428-001	PREVACID	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD	2002-08-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021428-002	PREVACID	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	AB	RLD, RS	2002-08-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021428-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021428-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021428-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021428-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021428-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021428-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021428-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021428-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021428-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021428-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021428-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021428-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021428-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021428-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021428-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021428-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021428-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021428-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021428-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021428-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021428-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021428-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021428-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021428-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021428-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021428-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021428-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021428-002	AB	1	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021428-001	6328994	2019-05-17		2002-10-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-001	7431942	2019-05-17	Drug product	2009-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-001	7875292	2019-05-17	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-001	9901546	2019-05-17	Drug product	2018-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-001	6328994*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-001	7431942*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-001	7875292*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-001	9901546*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	6328994	2019-05-17		2002-10-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	7431942	2019-05-17	Drug product	2009-01-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	7875292	2019-05-17	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	9901546	2019-05-17	Drug product	2018-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	6328994*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	7431942*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	7875292*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021428-002	9901546*PED	2019-11-17	Pediatric extension		`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021428-001	6328994	2019-05-17		2002-10-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-001	7431942	2019-05-17	Drug product	2009-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-001	7875292	2019-05-17	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-001	9901546	2019-05-17	Drug product	2018-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-001	6328994*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-001	7431942*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-001	7875292*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-001	9901546*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	6328994	2019-05-17		2002-10-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	7431942	2019-05-17	Drug product	2009-01-22	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	7875292	2019-05-17	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	9901546	2019-05-17	Drug product	2018-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	6328994*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	7431942*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	7875292*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021428-002	9901546*PED	2019-11-17	Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021428-001	6328994	2019-05-17		2002-10-28	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021428-001	7431942	2019-05-17	Drug product	2009-01-22	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021428-001	7875292	2019-05-17	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021428-001	9901546	2019-05-17	Drug product	2018-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021428-001	6328994*PED	2019-11-17	Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021428-001	7431942*PED	2019-11-17	Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021428-001	7875292*PED	2019-11-17	Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021428-001	9901546*PED	2019-11-17	Pediatric extension		`b00525d2431f…`

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): 021428 application number: NDA021428 ndc (product): 64764-544 ndc (product): 64764-543

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-106	Prevacid SoluTab	lansoprazole	Rebel Distributors Corp	NDA	Current
55154-0253	Prevacid	lansoprazole	Cardinal Health	NDA	Current
55154-0253	Prevacid	lansoprazole	Cardinal Health 107, LLC	NDA	Current
55154-0253	Prevacid	lansoprazole	Cardinal Health	NDA	Current
64764-543	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-543	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-543	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-543	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-543	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-543	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-543	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-544	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-544	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-544	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-544	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-544	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-544	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-544	Prevacid SoluTab	lansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77890	SUPPL	2023-08-10
77891	SUPPL	2023-08-09
70479	SUPPL	2022-03-10
70464	SUPPL	2022-03-10
70410	SUPPL	2022-03-07
65415	SUPPL	2020-11-30
65414	SUPPL	2020-11-30
65376	SUPPL	2020-11-30
64587	SUPPL	2020-09-17
64568	SUPPL	2020-09-14
54573	SUPPL	2018-06-14
54572	SUPPL	2018-06-14
54518	SUPPL	2018-06-11
54517	SUPPL	2018-06-11
54516	SUPPL	2018-06-11
53708	SUPPL	2018-04-17
53695	SUPPL	2018-04-16
50184	SUPPL	2017-10-25
50101	SUPPL	2017-10-19
45713	SUPPL	2016-10-31
45663	SUPPL	2016-10-26
27750	SUPPL	2015-12-18
36899	SUPPL	2015-12-17
36900	SUPPL	2014-12-29
27751	SUPPL	2014-12-24
5349	SUPPL	2012-10-02
36898	SUPPL	2012-10-01
5350	SUPPL	2012-05-09
15447	SUPPL	2012-05-07
23659	ORIG	2011-12-20
15446	SUPPL	2011-11-01
27749	SUPPL	2011-10-31
36896	SUPPL	2011-06-07
5347	SUPPL	2011-06-03
36897	SUPPL	2011-05-26
5348	SUPPL	2011-05-25
15445	SUPPL	2010-09-10
36895	SUPPL	2010-05-17
5346	SUPPL	2010-05-17
27748	SUPPL	2009-11-12
15444	SUPPL	2009-08-13
15443	SUPPL	2008-11-07
27747	SUPPL	2008-10-29
21650	SUPPL	2008-07-31
5345	SUPPL	2008-04-23
5344	SUPPL	2007-07-05
15442	SUPPL	2007-06-27
36894	SUPPL	2006-04-13
5343	SUPPL	2006-04-13
42153	ORIG	2005-06-23
36893	SUPPL	2004-12-21
27746	SUPPL	2004-06-23
5342	SUPPL	2003-08-15
27745	ORIG	2002-08-30
15441	ORIG	2002-08-30