Home Applications 074352 Application 074352
Type ANDA
Sponsor HI TECH PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE SOLUTION;ORAL 1MG/5ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A074352-001 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17
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 · 43 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 2026-09-14 22:38:34 2026-08 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074352-001 LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION / ORAL 1995-11-17 f41ea6bd6efb…
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 7 of 7 · 132 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 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17856-0618 Loperamide Hydrochloride Loperamide Hydrochloride Atlantic Biologicals Corps ANDA Current 17856-0618 Loperamide Hydrochloride Loperamide Hydrochloride Atlantic Biologicals Corps ANDA Current 50090-0461 Loperamide Hydrochloride Loperamide Hydrochloride A-S Medication Solutions ANDA Current 50383-618 Loperamide Hydrochloride Loperamide Hydrochloride Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-618 Loperamide Hydrochloride Loperamide Hydrochloride Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-618 Loperamide Hydrochloride Loperamide Hydrochloride Akorn ANDA Current 68151-0618 Loperamide Hydrochloride Loperamide Hydrochloride Carilion Materials Management ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current 68788-9773 Loperamide Hydrochloride Loperamide Hydrochloride Preferred Pharmaceuticals, Inc. ANDA Current