Application 076497
- Type
- ANDA
- Sponsor
- LNK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| 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.
| 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 | 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076497-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2003-06-10 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50844-735 | Loperamide HCl | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 50844-753 | Anti Diarrheal | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 50844-753 | Anti Diarrheal | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 50844-753 | Anti Diarrheal | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 50844-753 | Anti Diarrheal | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 50844-753 | Anti Diarrheal | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 50844-753 | Anti Diarrheal | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 50844-753 | Anti Diarrheal | Loperamide HCl | L.N.K. International, Inc. | ANDA | Current |
| 53117-248 | Anti-Diarrheal | Loperamide HCl | First Aid Direct | ANDA | Current |
| 53117-248 | Anti-Diarrheal | Loperamide HCl | First Aid Direct | ANDA | Current |
| 53943-375 | Anti-Diarrheal | Loperamide HCl | Discount Drug Mart | ANDA | Current |
| 53943-375 | Anti-Diarrheal | Loperamide HCl | Discount Drug Mart | ANDA | Current |
| 53943-375 | Anti-Diarrheal | Loperamide HCl | Discount Drug Mart | ANDA | Current |
| 53943-375 | Anti-Diarrheal | Loperamide HCl | Discount Drug Mart | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-375 | Anti Diarrheal | Loperamide HCl | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55315-975 | Anti-Diarrheal | Loperamide HCl | FRED'S, INC. | ANDA | Current |
| 55315-975 | Anti-Diarrheal | Loperamide HCl | FRED'S, INC. | ANDA | Current |
| 55315-975 | Anti-Diarrheal | Loperamide HCl | FRED'S, INC. | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 55319-375 | Anti-Diarrheal | Loperamide HCl | Family Dollar Services Inc | ANDA | Current |
| 57896-381 | Anti-Diarrheal | Loperamide HCl | Geri-Care Pharmaceutical Corp | ANDA | Current |
| 57896-381 | Anti-Diarrheal | Loperamide HCl | Geri-Care Pharmaceutical Corp | ANDA | Current |
| 57896-381 | Anti-Diarrheal | Loperamide HCl | Geri-Care Pharmaceutical Corp | ANDA | Current |
| 57896-381 | Anti-Diarrheal | Loperamide HCl | Geri-Care Pharmaceutical Corp | ANDA | Current |
| 57896-381 | Anti-Diarrheal | Loperamide HCl | Geri-Care Pharmaceutical Corp | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63868-559 | Anti Diarrheal | Loperamide HCl | CHAIN DRUG MARKETING ASSOCIATION INC | ANDA | Current |
| 63940-375 | Anti Diarrheal | Loperamide HCl | Harmon Store Inc. | ANDA | Current |
| 63940-375 | Anti Diarrheal | Loperamide HCl | Harmon Store Inc. | ANDA | Current |
| 63940-375 | Anti Diarrheal | Loperamide HCl | Harmon Store Inc. | ANDA | Current |
| 63941-375 | Anti-Diarrheal | Loperamide HCl | Valu Merchandisers Company | ANDA | Current |
| 63941-375 | Anti-Diarrheal | Loperamide HCl | Valu Merchandisers Company | ANDA | Current |
| 63941-375 | Anti-Diarrheal | Loperamide HCl | Valu Merchandisers Company | ANDA | Current |
| 63941-375 | Anti-Diarrheal | Loperamide HCl | Valu Merchandisers Company | ANDA | Current |
| 64092-105 | Anti-Diarrheal | Loperamide HCl | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. | ANDA | Current |
| 64092-105 | Anti-Diarrheal | Loperamide HCl | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. | ANDA | Current |
| 64092-105 | Anti-Diarrheal | Loperamide HCl | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. | ANDA | Current |
| 64092-105 | Anti-Diarrheal | Loperamide HCl | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. | ANDA | Current |
| 64092-105 | Anti-Diarrheal | Loperamide HCl | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. | ANDA | Current |
| 64092-105 | Anti-Diarrheal | Loperamide HCl | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. | ANDA | Current |
| 66424-735 | ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets | Loperamide HCL | SDA Laboratories, Inc. | ANDA | Current |
| 66424-735 | ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets | Loperamide HCL | SDA Laboratories, Inc. | ANDA | Current |
| 66424-735 | ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets | Loperamide HCL | SDA Laboratories, Inc. | ANDA | Current |
| 66424-735 | ANTI-DIARRHEAL LOPERAMIDE HCL, 2 mg caplets | Loperamide HCL | SDA Laboratories, Inc. | ANDA | Current |
| 67091-335 | Anti-Diarrheal | Loperamide HCl | WinCo Foods, LLC | ANDA | Current |
| 67091-335 | Anti-Diarrheal | Loperamide HCl | WinCo Foods, LLC | ANDA | Current |
| 67091-335 | Anti-Diarrheal | Loperamide HCl | WinCo Foods, LLC | ANDA | Current |
| 67091-335 | Anti-Diarrheal | Loperamide HCl | WinCo Foods, LLC | ANDA | Current |
| 67091-335 | Anti-Diarrheal | Loperamide HCl | WinCo Foods, LLC | ANDA | Current |
| 67091-405 | Anti Diarrheal | Loperamide HCL | WinCo Foods | ANDA | Current |
| 68016-301 | Anti-diarrheal | Loperamide HCl | Chain Drug Consortium | ANDA | Current |
| 68016-301 | Anti-diarrheal | Loperamide HCl | Chain Drug Consortium | ANDA | Current |
| 68016-301 | Anti-diarrheal | Loperamide HCl | Chain Drug Consortium | ANDA | Current |
| 68016-301 | Anti-diarrheal | Loperamide HCl | Chain Drug Consortium | ANDA | Current |
| 68016-638 | Anti-diarrheal | Loperamide HCl | Chain Drug Consortium | ANDA | Current |
| 68016-638 | Anti-diarrheal | Loperamide HCl | Chain Drug Consortium | ANDA | Current |
| 68196-975 | anti-diarrheal | Loperamide HCl | Sam's West Inc | ANDA | Current |
| 68196-975 | anti-diarrheal | Loperamide HCl | Sam's West Inc | ANDA | Current |
| 68196-975 | anti-diarrheal | Loperamide HCl | Sam's West Inc | ANDA | Current |