Application 020448

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMODIUM A-D EZ CHEWS	LOPERAMIDE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	2MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020448-001	IMODIUM A-D EZ CHEWS	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET, CHEWABLE / ORAL		RLD	1997-07-24

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020448-001	IMODIUM A-D EZ CHEWS	2MG	TABLET, CHEWABLE / ORAL	RLD	1997-07-24	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020448-001	6814978	2021-08-26	Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N020448-001	6814978	2021-08-26	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020448-001	6814978	2021-08-26	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020448-001	6814978	2021-08-26	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020448-001	6814978	2021-08-26	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020448-001	6814978	2021-08-26	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020448-001	6814978	2021-08-26	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020448-001	6814978	2021-08-26	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020448-001	6814978	2021-08-26	Drug product	`ea99ee380514…`

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 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	5a728c6d-26ec-3316-e063-6394a90ade08	2026-09-09	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	CVS Pharmacy	d8a55fb6-bb57-42d6-8e20-67fc91f38097	2026-09-04	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	f9a53a23-a8ea-4521-8f0b-1bc2a658ff68	2026-08-28	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Strides Pharma, Inc.	4178b3cc-e1ca-4912-8b1f-eac0110a3940	2026-08-13	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	568064c9-139d-7233-e063-6294a90a10d4	2026-08-10	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	REMEDYREPACK INC.	3fdfc0e5-56a2-48a0-8ee6-390a194a29f3	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	be99224e-dd49-4628-a5bf-ed8469ffd4a4	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	74b9893a-18c3-4117-85c2-edab8e7b3b3b	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Kesin Pharma Corporation	52e6ecc5-5f3d-9989-e063-6294a90af2dc	2026-06-30	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	eb93a17e-7daf-4a9e-94a1-442039a383bd	2026-06-26	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Cardinal Health 107, LLC	ca8de42f-8aea-4e35-ab3a-75ecea718f4f	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurobindo Pharma Limited	8e4004be-bf79-4631-9e38-c4e7b6726313	2026-06-03	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	5e1358fc-76de-486a-80dd-7f41e037d9a0	2026-06-01	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d7	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf	2026-05-28	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	L. Perrigo Company	9c1d811d-f8d0-418c-aaf7-7b6477deea20	2026-05-20	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Coupler LLC	518bb0f0-88f2-1c95-e063-6294a90a722f	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	a2594967-e737-4a23-a710-290ca0e6a272	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
berkley and jensen anti diarrheal	LOPERAMIDE HYDROCHLORIDE	BJWC	dc29a8e9-f916-49d2-b9a6-d2b4537d7b58	2026-05-08	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	ac674e5a-94df-4a35-9854-4e66cc17e509	2026-04-24	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48031	SUPPL	2017-04-14
48011	SUPPL	2017-04-13
24971	SUPPL	2007-01-16
12582	SUPPL	2007-01-16
41368	ORIG	2003-08-08