Home Applications 091292 Application 091292
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE SUSPENSION;ORAL 1MG/7.5ML 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 A091292-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20
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 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SUSPENSION / ORAL 2011-05-20 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 · 26 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 119 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0645 good sense loperamide hydrochloride loperamide HCl L. Perrigo Company ANDA Current 0113-1645 Good Sense antidiarrheal loperamide HCl L. Perrigo Company ANDA Current 0113-1645 Good Sense antidiarrheal loperamide HCl L. Perrigo Company ANDA Current 0363-0645 loperamide hydrochloride loperamide HCl Walgreen Company ANDA Current 0363-1645 loperamide hydrochloride loperamide HCl Walgreen Company ANDA Current 0363-1645 loperamide hydrochloride loperamide HCl Walgreen Company ANDA Current 0363-1645 loperamide hydrochloride loperamide HCl Walgreen Company ANDA Current 0363-2022 Anti Diarrheal loperamide HCl Walgreen Company ANDA Current 0904-6256 loperamide hydrochloride loperamide HCl Major Pharmaceuticals ANDA Current 0904-6836 loperamide hydrochloride loperamide HCl Major Pharmaceuticals ANDA Current 0904-6836 loperamide hydrochloride loperamide HCl Major Pharmaceuticals ANDA Current 0904-6836 loperamide hydrochloride loperamide HCl Major Pharmaceuticals ANDA Current 10202-645 7 select anti diarrheal loperamide HCl 7-Eleven ANDA Current 10202-645 7 select anti diarrheal loperamide HCl 7-Eleven ANDA Current 11673-900 Up and Up anti diarrheal loperamide HCl Target Corporation ANDA Current 11673-900 Up and Up anti diarrheal loperamide HCl Target Corporation ANDA Current 11822-1645 loperamide hydrochloride loperamide HCl Rite Aid Corporation ANDA Current 11822-5519 loperamide hydrochloride loperamide HCl Rite Aid Corporation ANDA Current 11822-5519 loperamide hydrochloride loperamide HCl Rite Aid Corporation ANDA Current 11822-5519 loperamide hydrochloride loperamide HCl Rite Aid Corporation ANDA Current 17856-0111 good neighbor pharmacy Loperamide hydrochloride loperamide HCl ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-0111 good neighbor pharmacy Loperamide hydrochloride loperamide HCl ATLANTIC BIOLOGICALS CORP ANDA Current 17856-0111 good neighbor pharmacy Loperamide hydrochloride loperamide HCl ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-0545 good neighbor pharmacy loperamide hydrochloride loperamide HCl ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-0545 good neighbor pharmacy loperamide hydrochloride loperamide HCl ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-6836 loperamide hydrochloride loperamide HCl ATLANTIC BIOLOGICALS CORP. ANDA Current 17856-6836 loperamide hydrochloride loperamide HCl ATLANTIC BIOLOGICALS CORP. ANDA Current 21130-131 signature care anti diarrheal loperamide HCl Safeway ANDA Current 21130-440 signature care anti diarrheal loperamide HCl Safeway ANDA Current 21130-440 signature care anti diarrheal loperamide HCl Safeway ANDA Current 30142-514 anti diarrheal loperamide HCl Kroger Company ANDA Current 30142-514 anti diarrheal loperamide HCl Kroger Company ANDA Current 30142-645 Loperamide Hydrochloride loperamide HCl Kroger Company ANDA Current 36800-583 topcare loperamide hydrochloride loperamide HCl Topco Associates LLC ANDA Current 36800-583 topcare loperamide hydrochloride loperamide HCl Topco Associates LLC ANDA Current 36800-583 topcare loperamide hydrochloride loperamide HCl Topco Associates LLC ANDA Current 36800-583 topcare loperamide hydrochloride loperamide HCl Topco Associates LLC ANDA Current 36800-645 topcare loperamide hydrochloride loperamide HCl Topco Associates LLC ANDA Current 37205-584 Leader Loperamide Hydrochloride loperamide HCl Cardinal Health ANDA Current 37808-449 anti diarrheal loperamide HCl H E B ANDA Current 37808-449 anti diarrheal loperamide HCl H E B ANDA Current 37808-645 Loperamide Hydrochloride loperamide HCl H E B ANDA Current 41163-210 equaline loperamide hydrochloride loperamide HCl Supervalu Inc ANDA Current 41163-210 equaline loperamide hydrochloride loperamide HCl Supervalu Inc ANDA Current 41163-645 Equaline loperamide hydrochloride loperamide HCl Supervalu Inc ANDA Current 41250-645 loperamide hydrochloride loperamide HCl Meijer Distribution Inc ANDA Current 41250-813 loperamide hydrochloride loperamide HCl Meijer Distribution Inc ANDA Current 41250-813 loperamide hydrochloride loperamide HCl Meijer Distribution Inc ANDA Current 41520-645 CareOne loperamide hydrochloride loperamide HCl American Sales Company ANDA Current 41520-767 CareOne Diarrhea Control loperamide HCl American Sales Company ANDA Current 41520-767 CareOne Diarrhea Control loperamide HCl American Sales Company ANDA Current 41520-841 CareOne Diarrhea Control Loperamide Hydrochloride American Sales Company ANDA Current 41520-841 CareOne Diarrhea Control Loperamide Hydrochloride American Sales Company ANDA Current 46122-111 good neighbor pharmacy Loperamide hydrochloride loperamide HCl Amerisource Bergen ANDA Current 46122-241 Good Neighbor Pharmacy Loperamide Hydrochloride Loperamide Hydrochloride Amerisource Bergen ANDA Current 46122-241 Good Neighbor Pharmacy Loperamide Hydrochloride Loperamide Hydrochloride Amerisource Bergen ANDA Current 46122-544 good neighbor pharmacy loperamide hydrochloride loperamide HCl Amerisource Bergen ANDA Current 46122-544 good neighbor pharmacy loperamide hydrochloride loperamide HCl Amerisource Bergen ANDA Current 46122-546 Good Neighbor Pharmacy Loperamide Hydrochloride Loperamide HCl Amerisource Bergen ANDA Current 49035-451 Equate Loperamide Hydrochloride loperamide HCl Wal-Mart Stores Inc ANDA Current 49035-451 Equate Loperamide Hydrochloride loperamide HCl Wal-Mart Stores Inc ANDA Current 49035-451 Equate Loperamide Hydrochloride loperamide HCl Wal-Mart Stores Inc ANDA Current 49035-451 Equate Loperamide Hydrochloride loperamide HCl Wal-Mart Stores Inc ANDA Current 49035-645 Equate Loperamide Hydrochloride loperamide HCl Wal-Mart Stores Inc ANDA Current 49035-645 Equate Loperamide Hydrochloride loperamide HCl Wal-Mart Stores Inc ANDA Current 49035-695 equate diarrhea control Loperamide HCl Wal-Mart Stores Inc ANDA Current 49348-999 sunmark loperamide hydrochloride loperamide HCl McKesson ANDA Current 49348-999 sunmark loperamide hydrochloride loperamide HCl Strategic Sourcing Services LLC ANDA Current 49738-383 Smart Sense anti diarrheal loperamide HCl Kmart Corporation ANDA Current 49738-645 smart sense loperamide hydrochloride loperamide HCl Kmart Corporation ANDA Current 49781-061 Leader Loperamide Hydrochloride loperamide HCl Cardinal Health ANDA Current 49781-089 leader loperamide Loperamide Hydrochloride Cardinal Health ANDA Current 50090-4450 sunmark anti diarrheal loperamide HCl A-S Medication Solutions ANDA Current 50090-4450 sunmark anti diarrheal loperamide HCl A-S Medication Solutions ANDA Current 55316-645 Healthy Accents Anti Diarrheal loperamide HCl DZA Brands LLC ANDA Current 55910-645 dg health loperamide hydrochloride loperamide HCl Dolgencorp Inc ANDA Current 55910-867 DG Health Anti Diarrheal loperamide HCl Dolgencorp Inc ANDA Current 59779-645 loperamide hydrochloride loperamide HCl CVS Pharmacy ANDA Current 59779-758 Loperamide Hydrochloride Loperamide Hydrochloride CVS Pharmacy ANDA Current 59779-758 Loperamide Hydrochloride Loperamide Hydrochloride CVS Pharmacy ANDA Current