Application 073192
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | CAPSULE;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A073192-001 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A073192-001 | AB |
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 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A073192-001 | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE / ORAL | AB | 1992-04-30 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A073192-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073192-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A073192-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073192-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073192-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073192-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073192-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073192-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073192-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A073192-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073192-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073192-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073192-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A073192-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073192-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A073192-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A073192-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A073192-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A073192-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A073192-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073192-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A073192-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A073192-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A073192-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A073192-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A073192-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A073192-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073192-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A073192-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A073192-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073192-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073192-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073192-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073192-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A073192-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A073192-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073192-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A073192-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A073192-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A073192-001 | AB | 1 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Cardinal Health 107, LLC | ca8de42f-8aea-4e35-ab3a-75ecea718f4f | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 55154-4699 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 45a1e6b0-1e2b-958a-e063-6394a90a261d | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | American Health Packaging | 42989f90-8ff5-44d1-a462-28c18ce02738 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 60687-229 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3310a3c2-389a-4b27-a478-67c905789854 | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 55289-315 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 580e6cd4-3f05-4996-9dc3-c50d757ae210 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 43063-020 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | A-S Medication Solutions | 97c37571-9116-40d6-ba07-f4a5a8d9b689 | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 50090-0460 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Bryant Ranch Prepack | 865cf4c7-f643-451b-b0d4-d30bda621f7d | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 63629-8747 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3e898141-8d40-49f1-e054-00144ff88e88 | 2024-08-13 | Warnings, Adverse reactions | 073192 ANDA073192 66267-132 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | af0b886f-c065-26dc-e053-2995a90ac471 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 68071-2257 |
| Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 8bf47ac3-746f-47c3-82b2-32ac979ff963 | 2016-11-30 | Boxed warning, Warnings, Adverse reactions | 073192 ANDA073192 0093-0311 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-0311 | Loperamide Hydrochloride | Loperamide Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0311 | Loperamide Hydrochloride | Loperamide Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0311 | Loperamide Hydrochloride | Loperamide Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0311 | Loperamide Hydrochloride | Loperamide Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-8012 | Loperamide Hydrochloride | Loperamide Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 21695-692 | Loperamide Hydrochloride | Loperamide Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 33261-344 | Loperamide Hydrochloride | Loperamide Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42708-074 | Loperamide Hydrochloride | Loperamide Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-074 | Loperamide Hydrochloride | Loperamide Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-074 | Loperamide Hydrochloride | Loperamide Hydrochloride | QPharma Inc | ANDA | Current |
| 43063-020 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-020 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-020 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-020 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-020 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-0460 | Loperamide Hydrochloride | Loperamide Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51655-547 | Loperamide hydrochloride | Loperamide hydrochloride | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53808-0707 | Loperamide Hydrochloride | LOPERAMIDE HYDROCHLORIDE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4699 | Loperamide Hydrochloride | Loperamide Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-4699 | Loperamide Hydrochloride | Loperamide Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4699 | Loperamide Hydrochloride | Loperamide Hydrochloride | Cardinal Health | ANDA | Current |
| 55289-315 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-315 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-315 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-315 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-315 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-315 | Loperamide Hydrochloride | Loperamide Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 60687-229 | Loperamide Hydrochloride | Loperamide Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-229 | Loperamide Hydrochloride | Loperamide Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-229 | Loperamide Hydrochloride | Loperamide Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-229 | Loperamide Hydrochloride | Loperamide Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-229 | Loperamide Hydrochloride | Loperamide Hydrochloride | American Health Packaging | ANDA | Current |
| 61919-423 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-423 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-423 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-423 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-423 | LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63629-1452 | Loperamide Hydrochloride | Loperamide Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8193 | Loperamide Hydrochloride | Loperamide Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8747 | Loperamide Hydrochloride | Loperamide Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8747 | Loperamide Hydrochloride | Loperamide Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 66267-132 | Loperamide Hydrochloride | Loperamide Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-132 | Loperamide Hydrochloride | Loperamide Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-797 | Loperamide Hydrochloride | Loperamide Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-797 | Loperamide Hydrochloride | Loperamide Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66336-046 | Loperamide Hydrochloride | Loperamide Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 67046-454 | Loperamide Hydrochloride | Loperamide Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0346 | Loperamide Hydrochloride | Loperamide Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0346 | Loperamide Hydrochloride | Loperamide Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0346 | Loperamide Hydrochloride | Loperamide Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2257 | Loperamide Hydrochloride | Loperamide Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2257 | Loperamide Hydrochloride | Loperamide Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4075 | Loperamide Hydrochloride | Loperamide Hydrochloride | NuCare pharmceuticals,Inc. | ANDA | Current |
| 68788-9079 | Loperamide Hydrochloride | Loperamide Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0052 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0052 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0072 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0072 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0072 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0072 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0072 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0072 | Loperamide Hydrochloride | Loperamide Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-546 | Loperamide Hydrochloride | Loperamide Hydrochloride | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-1569 | Loperamide Hydrochloride | Loperamide Hydrochloride | Bryant Ranch Prepack | ANDA | Current |