Home Applications 019487 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 42 .
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IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1988-03-01 N019487-002 IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL RLD, RS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 1 of 3 · 84 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 2026-08-18 06:07:40 2026-07 N019487-001 IMODIUM A-D 1MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / ORAL RLD 1988-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019487-002 IMODIUM A-D 1MG/7.5ML SOLUTION / ORAL RLD, RS 2004-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD 1988-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019487-002 IMODIUM A-D 1MG/7.5ML SOLUTION / ORAL RLD, RS 2004-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD 1988-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019487-002 IMODIUM A-D 1MG/7.5ML SOLUTION / ORAL RLD, RS 2004-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD 1988-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019487-001 IMODIUM A-D 1MG/5ML SOLUTION / ORAL RLD, RS 1988-03-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019487-002 IMODIUM A-D 1MG/7.5ML SUSPENSION / ORAL RLD, RS 2004-07-08 4b0b4de00fa7…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…
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.
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