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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091292-001 LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML SOLUTION / ORAL 2011-05-20 caaa826d4ba7…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…
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 2 of 2 · 27 matching rows.
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 2 of 2 · 119 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62011-0151 health mart loperamide hydrochloride loperamide HCl McKesson ANDA Current 62011-0151 health mart loperamide hydrochloride loperamide HCl Strategic Sourcing Services LLC ANDA Current 62011-0236 Health Mart Loperamide Hydrochloride Loperamide Hydrochloride Strategic Sourcing Services LLC ANDA Current 62011-0236 Health Mart Loperamide Hydrochloride Loperamide Hydrochloride McKesson ANDA Current 62011-0383 health mart anti diarrheal loperamide HCl McKesson ANDA Current 62011-0383 health mart anti diarrheal loperamide HCl Strategic Sourcing Services LLC ANDA Current 62011-0383 health mart anti diarrheal loperamide HCl Strategic Sourcing Services LLC ANDA Current 62011-0385 health mart anti diarrheal Loperamide HCl Strategic Sourcing Services LLC ANDA Current 62011-0385 health mart anti diarrheal Loperamide HCl McKesson ANDA Current 62011-0385 health mart anti diarrheal Loperamide HCl Strategic Sourcing Services LLC ANDA Current 68094-029 Loperamide Hydrochloride Loperamide Hydrochloride Precision Dose, Inc. ANDA Current 68094-107 Loperamide Hydrochloride Loperamide Hydrochloride Precision Dose Inc. ANDA Current 68094-107 Loperamide Hydrochloride Loperamide Hydrochloride Precision Dose Inc. ANDA Current 68094-108 Loperamide Hydrochloride Loperamide Hydrochloride Precision Dose Inc. ANDA Current 68094-108 Loperamide Hydrochloride Loperamide Hydrochloride Precision Dose Inc. ANDA Current 68094-129 Loperamide Hydrochloride Loperamide Hydrochloride Precision Dose, Inc. ANDA Current 68094-129 Loperamide Hydrochloride Loperamide Hydrochloride Precision Dose, Inc. ANDA Current 68788-7842 loperamide hydrochloride loperamide HCl Preferred Pharmaceuticals Inc. ANDA Current 68788-7842 loperamide hydrochloride loperamide HCl Preferred Pharmaceuticals Inc. ANDA Current 68788-9704 loperamide hydrochloride loperamide HCl Preferred Pharmaceuticals, Inc. ANDA Current 68788-9704 loperamide hydrochloride loperamide HCl Preferred Pharmaceuticals, Inc. ANDA Current 69256-005 harris teeter anti diarrheal loperamide HCl Harris Teeter, LLC ANDA Current 69256-005 harris teeter anti diarrheal loperamide HCl Harris Teeter, LLC ANDA Current 69256-645 Harris Teeter Loperamide Hydrochloride loperamide HCl Harris Teeter, LLC ANDA Current 69842-191 Loperamide hydrochloride loperamide HCl CVS Pharmacy ANDA Current 69842-191 Loperamide hydrochloride loperamide HCl CVS Pharmacy ANDA Current 70000-0224 Leader Anti Diarrheal loperamide HCl Cardinal Health ANDA Current 70000-0417 leader anti diarrheal loperamide HCl Cardinal Health ANDA Current 70000-0417 leader anti diarrheal loperamide HCl Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0417 leader anti diarrheal loperamide HCl Cardinal Health ANDA Current 70000-0418 leader anti diarrheal Loperamide HCl Cardinal Health ANDA Current 70000-0418 leader anti diarrheal Loperamide HCl Cardinal Health 110, LLC. dba Leader ANDA Current 70000-0418 leader anti diarrheal Loperamide HCl Cardinal Health ANDA Current 70166-087 leader loperamide Loperamide Hydrochloride Lohxa ANDA Current 70677-0054 sunmark anti diarrheal loperamide HCl McKesson ANDA Current 70677-0054 sunmark anti diarrheal loperamide HCl Strategic Sourcing Services LLC ANDA Current 70677-0054 sunmark anti diarrheal loperamide HCl Strategic Sourcing Services LLC ANDA Current 72288-645 basic care loperamide hydrochloride loperamide HCl Amazon.com Services LLC ANDA Current 72288-758 basic care loperamide hydrochloride Loperamide hydrochloride Amazon.com Services LLC ANDA Current