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 5 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	NuCare Pharmaceuticals,Inc.	df4e7076-fd25-aeb8-e053-2995a90a2aa0	2024-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	SDA Laboratories, Inc.	d954ff63-f096-45e8-a0b6-f22e323b113f	2024-04-18	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	691c5dd6-b85d-482b-a8c1-8c4b48b48dc9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Amerisource Bergen	6c15f077-9f90-4262-9c17-a1ac70e45f57	2024-03-29	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c5322892-cb14-4a25-9b42-e62e491bc101	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Consortium, LLC	b070896b-1e22-41d4-a66d-8d3be1699217	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Zee Medical Inc	07e1f89c-5bf6-4539-848a-4435e7deb0d2	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Ohm Laboratories Inc.	c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Discount Drug Mart	6bc9771d-09f8-47ce-bbbd-8dd9aae97693	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Marc Glassman, Inc.	01efdce1-25ce-45ff-aeb6-f6fba00e59aa	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Valu Merchandisers Company	33335063-49a9-4e08-9d77-4cd80e94f021	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Fred's Inc.	a3bf91ae-22f3-4402-b73c-de026f2d0475	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	237b845b-0f02-410d-9750-c95123e6142d	2024-01-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	6e60cb25-6af9-4f17-b740-a5e7b5bb2a09	2023-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	a14bd404-cc79-06e0-e053-2a95a90a6841	2023-12-26	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	fed347ad-cfbb-9ee8-e053-6394a90ad275	2023-10-10	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Aurobindo Pharma Limited	8d142533-4e87-4030-8fe9-4fc7473b0442	2023-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	6fe91ddc-06b6-3a51-2b48-f6f11361ab73	2023-06-25	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	356d9432-d948-4b88-b297-9161b845f86b	2023-06-25	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide hydrochloride	LOPERAMIDE HYDROCHLORIDE	Viona Pharmaceuticals Inc	330677ff-5426-40bd-af45-e3836cb77893	2023-06-19	Boxed warning, Warnings, Adverse reactions	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