Application 209837
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | TABLET;ORAL | 2MG;125MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 |
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 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A209837-001 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | 2MG;125MG | TABLET / ORAL | 2018-09-05 | 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 |
|---|---|---|---|---|---|
| 0113-0087 | good sense anti diarrheal anti gas | loperamide hydrochloride, simethicone | L. Perrigo Company | ANDA | Current |
| 0113-0087 | good sense anti diarrheal anti gas | loperamide hydrochloride, simethicone | L Perrigo Company | ANDA | Current |
| 0113-1087 | Good Sense Anti Diarrheal Anti Gas | loperamide hydrochloride, simethicone | L. Perrigo Company | ANDA | Current |
| 0113-7119 | basic care loperamide hydrochloride and simethicone | loperamide hydrochloride, simethicone | L. Perrigo Company | ANDA | Current |
| 0113-7119 | basic care loperamide hydrochloride and simethicone | loperamide hydrochloride, simethicone | L. Perrigo Company | ANDA | Current |
| 0363-1830 | anti diarrheal and anti gas | loperamide hydrochloride, simethicone | Walgreen Company | ANDA | Current |
| 0363-1830 | anti diarrheal and anti gas | loperamide hydrochloride, simethicone | Walgreen Company | ANDA | Current |
| 0363-1830 | anti diarrheal and anti gas | loperamide hydrochloride, simethicone | Walgreen Company | ANDA | Current |
| 11673-646 | up and up anti diarrheal anti gas | loperamide hydrochloride, simethicone | Target Corporation | ANDA | Current |
| 11673-646 | up and up anti diarrheal anti gas | loperamide hydrochloride, simethicone | Target Corporation | ANDA | Current |
| 11673-646 | up and up anti diarrheal anti gas | loperamide hydrochloride, simethicone | Target Corporation | ANDA | Current |
| 11822-1003 | anti diarrheal anti gas | loperamide hydrochloride, simethicone | Rite Aid Corporation | ANDA | Current |
| 11822-1003 | anti diarrheal anti gas | loperamide hydrochloride, simethicone | Rite Aid Corporation | ANDA | Current |
| 21130-183 | signature care anti diarrheal anti gas | loperamide hydrochloride, simethicone | Safeway | ANDA | Current |
| 21130-183 | signature care anti diarrheal anti gas | loperamide hydrochloride, simethicone | Safeway | ANDA | Current |
| 21130-183 | signature care anti diarrheal anti gas | loperamide hydrochloride, simethicone | Safeway | ANDA | Current |
| 30142-581 | Anti Diarrheal Anti Gas | Loperamide Hydrochloride, Simethicone | Kroger Company | ANDA | Current |
| 30142-581 | Anti Diarrheal Anti Gas | Loperamide Hydrochloride, Simethicone | Kroger Company | ANDA | Current |
| 36800-633 | topcare anti diarrheal anti gas | loperamide hydrochloride, simethicone | Topco Associates LLC | ANDA | Current |
| 36800-633 | topcare anti diarrheal anti gas | loperamide hydrochloride, simethicone | Topco Associates LLC | ANDA | Current |
| 36800-633 | topcare anti diarrheal anti gas | loperamide hydrochloride, simethicone | Topco Associates LLC | ANDA | Current |
| 36800-633 | topcare anti diarrheal anti gas | loperamide hydrochloride, simethicone | Topco Associates LLC | ANDA | Current |
| 37808-714 | anti diarrheal anti gas | loperamide hydrochloride, simethicone | H E B | ANDA | Current |
| 37808-714 | anti diarrheal anti gas | loperamide hydrochloride, simethicone | H E B | ANDA | Current |
| 37808-714 | anti diarrheal anti gas | loperamide hydrochloride, simethicone | H E B | ANDA | Current |
| 41163-553 | equaline anti diarrheal plus anti gas | loperamide hydrochloride, simethicone | Supervalu Inc | ANDA | Current |
| 41250-375 | anti diarrheal plus anti gas | loperamide hydrochloride, simethicone | Meijer Distribution Inc | ANDA | Current |
| 41250-375 | anti diarrheal plus anti gas | loperamide hydrochloride, simethicone | Meijer Distribution Inc | ANDA | Current |
| 41250-375 | anti diarrheal plus anti gas | loperamide hydrochloride, simethicone | Meijer Distribution Inc | ANDA | Current |
| 41520-772 | CareOne Diarrhea and Gas Control | loperamide hydrochloride, simethicone | American Sales Company | ANDA | Current |
| 41520-772 | CareOne Diarrhea and Gas Control | loperamide hydrochloride, simethicone | American Sales Company | ANDA | Current |
| 46122-566 | Anti Diarrheal Anti Gas | loperamide hydrochloride, simethicone | Amerisource Bergen | ANDA | Current |
| 46122-566 | Anti Diarrheal Anti Gas | loperamide hydrochloride, simethicone | Amerisource Bergen | ANDA | Current |
| 46122-620 | good neighbor pharmacy anti diarrheal anti gas | loperamide hydrochloride, simethicone | Amerisource Bergen | ANDA | Current |
| 46122-620 | good neighbor pharmacy anti diarrheal anti gas | loperamide hydrochloride, simethicone | Amerisource Bergen | ANDA | Current |
| 49035-549 | equate anti diarrheal anti gas | loperamide hydrochloride, simethicone | Wal-Mart Stores Inc | ANDA | Current |
| 49035-549 | equate anti diarrheal anti gas | loperamide hydrochloride, simethicone | Wal-Mart Stores Inc | ANDA | Current |
| 49035-549 | equate anti diarrheal anti gas | loperamide hydrochloride, simethicone | Wal-Mart Stores Inc | ANDA | Current |
| 55319-106 | family wellness anti diarrheal plus multi symptom relief | loperamide hydrochloride, simethicone | Family Dollar Services Inc | ANDA | Current |
| 55319-823 | family wellness anti diarrheal plus anti gas | loperamide hydrochloride, simethicone | Family Dollar Services Inc | ANDA | Current |
| 55319-823 | family wellness anti diarrheal plus anti gas | loperamide hydrochloride, simethicone | Family Dollar Services Inc | ANDA | Current |
| 55319-823 | family wellness anti diarrheal plus anti gas | loperamide hydrochloride, simethicone | Family Dollar Services Inc | ANDA | Current |
| 55910-383 | dg health anti diarrheal anti gas | loperamide hydrochloride, simethicone | Dolgencorp, LLC | ANDA | Current |
| 55910-383 | dg health anti diarrheal anti gas | loperamide hydrochloride, simethicone | Dolgencorp, LLC | ANDA | Current |
| 55910-383 | dg health anti diarrheal anti gas | loperamide hydrochloride, simethicone | Dolgencorp, LLC | ANDA | Current |
| 55910-383 | dg health anti diarrheal anti gas | loperamide hydrochloride, simethicone | Dolgencorp, LLC | ANDA | Current |
| 56062-511 | antidiarrheal multi symptom relief | loperamide hydrochloride, simethicone | Publix Super Markets Inc | ANDA | Current |
| 62011-0365 | health mart anti diarrheal anti gas | loperamide hydrochloride, simethicone | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0365 | health mart anti diarrheal anti gas | loperamide hydrochloride, simethicone | Mckesson | ANDA | Current |
| 62011-0365 | health mart anti diarrheal anti gas | loperamide hydrochloride, simethicone | Mckesson | ANDA | Current |
| 62011-0365 | health mart anti diarrheal anti gas | loperamide hydrochloride, simethicone | Strategic Sourcing Services LLC | ANDA | Current |
| 69842-644 | anti diarrheal and anti gas | loperamide hydrochloride, simethicone | CVS Pharmacy | ANDA | Current |
| 69842-644 | anti diarrheal and anti gas | loperamide hydrochloride, simethicone | CVS Pharmacy | ANDA | Current |
| 69842-807 | loperamide hydrochloride and simethicone | loperamide hydrochloride, simethicone | CVS Pharmacy | ANDA | Current |
| 69842-807 | loperamide hydrochloride and simethicone | loperamide hydrochloride, simethicone | CVS Pharmacy | ANDA | Current |
| 72288-001 | Basic Care Loperamide Hydrochloride and Simethicone | loperamide hydrochloride, simethicone | Amazon.com Services LLC | ANDA | Current |
| 72288-001 | Basic Care Loperamide Hydrochloride and Simethicone | loperamide hydrochloride, simethicone | Amazon.com Services Inc. | ANDA | Current |