Home Applications 075232 Application 075232
Type ANDA
Sponsor L PERRIGO CO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE TABLET;ORAL 2MG No No
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 A075232-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075232-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2000-01-06 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 2 · 25 matching rows.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 123 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59779-700 anti diarrheal Loperamide Hydrochloride CVS Pharmacy ANDA Current 59779-700 anti diarrheal Loperamide Hydrochloride CVS Pharmacy ANDA Current 59779-700 anti diarrheal Loperamide Hydrochloride CVS Pharmacy ANDA Current 59779-960 anti diarrheal Loperamide HCl CVS Pharmacy ANDA Current 59779-960 anti diarrheal Loperamide HCl CVS Pharmacy ANDA Current 59779-960 anti diarrheal Loperamide HCl CVS Pharmacy ANDA Current 61715-109 Preferred Plus Loperamide Hydrochloride Loperamide HCl Kinray ANDA Current 62011-0150 health mart anti diarrheal Loperamide HCl Strategic Sourcing Services LLC ANDA Current 62011-0150 health mart anti diarrheal Loperamide HCl McKesson ANDA Current 62011-0150 health mart anti diarrheal Loperamide HCl McKesson ANDA Current 62011-0150 health mart anti diarrheal Loperamide HCl Strategic Sourcing Services LLC ANDA Current 63940-119 core values anti diarrheal Loperamide HCl Harmon Stores Inc. ANDA Current 63940-119 core values anti diarrheal Loperamide HCl Harmon Stores Inc. ANDA Current 63940-119 core values anti diarrheal Loperamide HCl Harmon Stores Inc. ANDA Current 63940-224 harmon face values anti diarrheal Loperamide HCl Harmon Stores Inc. ANDA Current 63940-224 harmon face values anti diarrheal Loperamide HCl Harmon Stores Inc. ANDA Current 63981-224 kirkland signature anti diarrheal Loperamide Hydrochloride Costco Wholesale Company ANDA Current 63981-224 kirkland signature anti diarrheal Loperamide Hydrochloride Costco Wholesale Company ANDA Current 68391-224 berkley and jensen anti diarrheal Loperamide Hydrochloride BJWC ANDA Current 68391-224 berkley and jensen anti diarrheal Loperamide Hydrochloride BJWC ANDA Current 68391-224 berkley and jensen anti diarrheal Loperamide Hydrochloride BJWC ANDA Current 68788-8951 anti diarrheal Loperamide Hydrochloride Preferred Pharmaceuticals Inc. ANDA Current 68788-8951 anti diarrheal Loperamide Hydrochloride Preferred Pharmaceuticals Inc. ANDA Current 68788-8951 anti diarrheal Loperamide Hydrochloride Preferred Pharmaceuticals Inc. ANDA Current 68788-8951 anti diarrheal Loperamide Hydrochloride Preferred Pharmaceuticals Inc. ANDA Current 68788-8951 anti diarrheal Loperamide Hydrochloride Preferred Pharmaceuticals Inc. ANDA Current 69256-224 Harris Teeter Anti Diarrheal Loperamide HCl Harris Teeter, LLC ANDA Current 69256-224 Harris Teeter Anti Diarrheal Loperamide HCl Harris Teeter, LLC ANDA Current 70000-0225 Leader Anti Diarrheal Loperamide HCl Cardinal Health ANDA Current 70000-0225 Leader Anti Diarrheal Loperamide HCl Cardinal Health ANDA Current 70000-0225 Leader Anti Diarrheal Loperamide HCl Cardinal Health ANDA Current 70000-0225 Leader Anti Diarrheal Loperamide HCl Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0589 leader anti diarrheal Loperamide HCl Cardinal Health 110, LLC. dba Leader ANDA Current 70518-0779 anti diarrheal Loperamide Hydrochloride REMEDYREPACK INC. ANDA Current 70518-0779 anti diarrheal Loperamide Hydrochloride REMEDYREPACK INC. ANDA Current 70518-1762 Leader Anti Diarrheal Loperamide HCl REMEDYREPACK INC. ANDA Current 71141-001 Anti Diarrheal Loperamide HCl Lidl US LLC ANDA Current 71141-001 Anti Diarrheal Loperamide HCl Lidl US LLC ANDA Current 71205-079 Good Sense anti diarrheal Loperamide Hydrochloride Proficient Rx LP ANDA Current 71205-079 Good Sense anti diarrheal Loperamide Hydrochloride Proficient Rx LP ANDA Current 71713-501 anti diarrheal Loperamide HCl THIRTY MADISON INC ANDA Current 72288-224 basic care loperamide hydrochloride Loperamide HCl Amazon.com Services LLC ANDA Current 76413-314 Loperamide hydrochloride Loperamide Hydrochloride Central Texas Community Health Centers ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42961 ORIG 2001-12-28 30806 ORIG 2000-01-06 18394 ORIG 2000-01-06