Home Applications 076497 Application 076497
Type ANDA
Sponsor LNK 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 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 A076497-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10
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 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076497-001 LOPERAMIDE HYDROCHLORIDE 2MG TABLET / ORAL 2003-06-10 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 · 30 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 3 of 3 · 177 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68196-975 anti-diarrheal Loperamide HCl Sam's West Inc ANDA Current 68788-7369 Anti-Diarrheal Loperamide HCl Preferred Pharmaceuticals Inc. ANDA Current 68788-7369 Anti-Diarrheal Loperamide HCl Preferred Pharmaceuticals Inc. ANDA Current 68788-7369 Anti-Diarrheal Loperamide HCl Preferred Pharmaceuticals Inc. ANDA Current 68788-7369 Anti-Diarrheal Loperamide HCl Preferred Pharmaceuticals Inc. ANDA Current 68788-7369 Anti-Diarrheal Loperamide HCl Preferred Pharmaceuticals Inc. ANDA Current 68998-248 Anti-Diarrheal Marc Glassman Marc Glassman, Inc. ANDA Current 68998-248 Anti-Diarrheal Marc Glassman Marc Glassman, Inc. ANDA Current 69168-248 Anti-Diarrheal Loperamide HCl Allegiant Health ANDA Current 69168-248 Anti-Diarrheal Loperamide HCl Allegiant Health ANDA Current 73581-101 WELMATE Anti Diarrheal Loperamide HCl LOPERAMIDE HYDROCHLORIDE YYBA CORP ANDA Current 76000-375 Anti Diarrheal Loperamide HCl Bedrock Brands, LLC ANDA Current 80136-063 Anti-Diarrheal Loperamide HCl Northeast Pharma ANDA Current 80136-063 Anti-Diarrheal Loperamide HCl Northeast Pharma ANDA Current 80136-063 Anti-Diarrheal Loperamide HCl Northeast Pharma ANDA Current 80136-381 Anti-Diarrheal Loperamide HCl Northeast Pharma ANDA Current 80136-381 Anti-Diarrheal Loperamide HCl Northeast Pharma ANDA Current