Application 019487

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	LOPERAMIDE HYDROCHLORIDE	SOLUTION;ORAL	1MG/5ML	Yes	Yes
002	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	SUSPENSION;ORAL	1MG/7.5ML	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
N019487-001	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	1MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1988-03-01
N019487-002	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL		RLD, RS	2004-07-08

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`3a93d1ddd44b…`

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
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	76a976d5-8bee-4158-a94d-7fbfc5544fd4	2025-09-23	Warnings	Exact identifier application applno (NDA): 019487 application number: NDA019487 ndc (product): 50580-134

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-134	Imodium	Loperamide Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-134	Imodium	Loperamide Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-134	Imodium	Loperamide Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59669	SUPPL	2019-08-13
59668	SUPPL	2019-08-12
48028	SUPPL	2017-04-14
48020	SUPPL	2017-04-14
11512	SUPPL	2016-04-11
1341	SUPPL	2016-04-07
11511	SUPPL	2015-03-24
17418	SUPPL	2015-03-19
20250	SUPPL	2008-07-31
40913	SUPPL	2008-07-30
20249	SUPPL	2008-04-04
1340	SUPPL	2005-06-09
1339	SUPPL	2004-07-14
17417	SUPPL	2004-06-16