Application 022327

Type: NDA
Sponsor: PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREVACID 24 HR	LANSOPRAZOLE	CAPSULE, DELAYED REL PELLETS;ORAL	15MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022327-001	PREVACID 24 HR	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL		RLD, RS	2009-05-18

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022327-001	PREVACID 24 HR	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	RLD, RS	2009-05-18	`cb3db0bc1861…`

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 5 · 100 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lansoprazole	LANSOPRAZOLE	Dr. Reddy's Laboratories Inc.	4a701c0d-fef5-aa12-01e6-e3680a161a7d	2026-07-21	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Redpharm Drug	56cafcf5-ce3d-a312-e063-6294a90a3db1	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Rugby Laboratories, Inc	aa95216c-8985-d160-1743-ba168a35177f	2026-07-17	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Dr. Reddy's Laboratories Inc.	a24acc0b-7770-1087-77bd-048259a5bf72	2026-07-15	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	LEADER/ Cardinal Health 110, Inc.	486838cd-17ee-c2df-4e05-aa6106dd8fd8	2026-07-15	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Dr. Reddy's Laboratories Limited	15e05eda-48aa-a4b7-4b8a-4ee1cf110120	2026-07-09	Warnings	Name fallback generic name: LANSOPRAZOLE
careone acid reducer	LANSOPRAZOLE	Retail Business Services, LLC	e6b42dec-3545-483f-97db-9375b3732fba	2026-07-08	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	dfdc9aa0-8612-9127-e053-2a95a90ae7c8	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Safecor Health LLC	47a8618c-e768-41bf-9116-634b564405d4	2026-06-18	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
BERKLEY AND JENSEN LANSOPRAZOLE	LANSOPRAZOLE	BJWC	b859e8dc-e42e-448d-89fa-2fc79d9cac32	2026-05-21	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Cardinal Health 107, LLC	c9a43df0-efab-4486-860f-92afdb258c8b	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals Inc.	db42468a-450c-4b12-b2f2-e9a76e976d45	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals, Inc.	7286d6a5-611b-4993-ab93-4899d599435d	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	AMERISOURCEBERGEN DRUG CORPORATION	accb92e8-dd14-b87b-c20a-6c4803815bc2	2026-04-17	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Asclemed USA, Inc.	71be1129-8562-476e-9d9b-99a21cbf52ec	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Major Pharmaceuticals	854e4235-4815-4461-9b9b-d3d783fb775d	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Walgreen Company	a72f92cc-db49-40ef-a249-6b7c50dc8ef2	2026-02-28	Warnings	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Medcore LLC	18b4020f-d7e6-42f8-838d-2b5da152530e	2026-01-16	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
Lansoprazole	LANSOPRAZOLE	Preferred Pharmaceuticals Inc.	960d6601-aec5-4900-a400-385b6687a4bc	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: LANSOPRAZOLE
good neighbor pharmacy lansoprazole	LANSOPRAZOLE	Amerisource Bergen	a4ee8db4-8f8e-4326-bd32-43abd53be8e4	2025-12-01	Warnings	Name fallback generic name: LANSOPRAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0067-6286	Prevacid	Lansoprazole	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6286	Prevacid	Lansoprazole	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6286	Prevacid	Lansoprazole	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0067-6286	Prevacid	Lansoprazole	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0113-6002	Prevacid 24 HR	lansoprazole	L. Perrigo Company	NDA	Current
0113-6002	Prevacid 24 HR	lansoprazole	L. Perrigo Company	NDA	Current
0113-6002	Prevacid 24 HR	lansoprazole	L. Perrigo Company	NDA	Current
0113-6002	Prevacid 24 HR	lansoprazole	L. Perrigo Company	NDA	Current
0113-6002	Prevacid 24 HR	lansoprazole	L. Perrigo Company	NDA	Current
68071-1883	Prevacid	Lansoprazole	NuCare Pharmaceuticals,Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73071	SUPPL	2023-01-03
73066	SUPPL	2023-01-03
71457	SUPPL	2022-06-27
71443	SUPPL	2022-06-24
70395	SUPPL	2022-03-03
70353	SUPPL	2022-03-02
58284	SUPPL	2019-04-10
58283	SUPPL	2019-04-10
50589	SUPPL	2017-12-04
50556	SUPPL	2017-12-01
47470	SUPPL	2017-03-06
47431	SUPPL	2017-03-02
29601	SUPPL	2015-07-09
38582	SUPPL	2015-07-02
38581	SUPPL	2013-11-26
38580	SUPPL	2013-11-26
38579	SUPPL	2013-11-26
38578	SUPPL	2013-11-26
38577	SUPPL	2013-11-26
17244	SUPPL	2013-11-26
17243	SUPPL	2013-11-26
17245	SUPPL	2013-11-19
29600	SUPPL	2012-09-24
29599	SUPPL	2012-04-25
29598	SUPPL	2012-04-09
44182	ORIG	2011-12-20
7243	SUPPL	2011-11-02
7242	SUPPL	2011-09-29
7241	SUPPL	2011-04-20
7240	SUPPL	2010-12-06
7239	SUPPL	2010-12-06
7238	SUPPL	2010-09-20
44738	ORIG	2009-08-03
42493	ORIG	2009-08-03
29597	ORIG	2009-05-22