Application 213413
- Type
- ANDA
- Sponsor
- LEADING PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | TABLET;ORAL | 0.025MG;2.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213413-001 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213413-001 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | 0.025MG;2.5MG | TABLET / ORAL | AA | 2020-02-20 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213413-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213413-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213413-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213413-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213413-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213413-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213413-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213413-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213413-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213413-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213413-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213413-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213413-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213413-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213413-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213413-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213413-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213413-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213413-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213413-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213413-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A213413-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A213413-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A213413-001 | AA | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213413-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A213413-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A213413-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213413-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213413-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213413-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213413-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A213413-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A213413-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213413-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A213413-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A213413-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213413-001 | AA | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213413-001 | AA | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | REMEDYREPACK INC. | 3d0e2877-7a74-433f-8a31-e3e54aa9dc9f | 2026-06-10 | Warnings, Adverse reactions | 213413 ANDA213413 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Redpharm Drug | 5342df5c-12bb-565c-e063-6294a90a4ade | 2026-06-02 | Warnings, Adverse reactions | 213413 ANDA213413 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Preferred Pharmaceuticals Inc. | 46d5b27b-a710-4767-b308-4f673ddb354c | 2026-04-06 | Warnings, Adverse reactions | 213413 ANDA213413 68788-8090 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | PD-Rx Pharmaceuticals, Inc. | 700aad61-fa8c-4ded-87b8-da966093075a | 2025-04-17 | Warnings, Adverse reactions | 213413 ANDA213413 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Redpharm Drug Inc. | f4c35a82-5927-5bc2-e053-2a95a90aea4d | 2025-01-23 | Warnings, Adverse reactions | 213413 ANDA213413 |
| DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Direct Rx | d9a36478-4788-4107-e053-2a95a90ad6da | 2025-01-21 | Adverse reactions | 213413 ANDA213413 72189-336 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | A-S Medication Solutions | 1be4dd7d-766c-4b3c-8b86-4f219ab44726 | 2024-11-13 | Warnings, Adverse reactions | 213413 ANDA213413 50090-5589 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Bryant Ranch Prepack | b3f58de9-1cc8-4bc5-842f-010cc48d3582 | 2024-08-23 | Warnings, Adverse reactions | 213413 ANDA213413 71335-1693 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Aphena Pharma Solutions - Tennessee, LLC | 14bf7191-580f-76dc-e063-6294a90aed2a | 2024-04-08 | Warnings, Adverse reactions | 213413 ANDA213413 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Leading Pharma, LLC | 1c188bc9-7c21-4717-94a0-cdfb581fb776 | 2023-02-15 | Warnings, Adverse reactions | 213413 ANDA213413 69315-910 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | A-S Medication Solutions | 24077113-11b2-4cde-afa7-1a1e364173c2 | 2023-02-06 | Warnings, Adverse reactions | 213413 ANDA213413 50090-5592 |
| Diphenoxylate Hydrochloride and Atropine Sulfate | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Proficient Rx LP | 593f2d01-5d24-450e-a6cf-204b7420f971 | 2022-03-01 | Warnings, Adverse reactions | 213413 ANDA213413 71205-909 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5589 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | A-S Medication Solutions | ANDA | Current |
| 50090-5592 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | A-S Medication Solutions | ANDA | Current |
| 53002-3401 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2328 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8090 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8090 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69315-910 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Leading Pharma, LLC | ANDA | Current |
| 69315-910 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Leading Pharma, LLC | ANDA | Current |
| 69315-910 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Leading Pharma, LLC | ANDA | Current |
| 71205-909 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Proficient Rx LP | ANDA | Current |
| 71205-909 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Proficient Rx LP | ANDA | Current |
| 71335-1693 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1693 | Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | Bryant Ranch Prepack | ANDA | Current |
| 72189-336 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Direct Rx | ANDA | Current |
| 72189-336 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Direct Rx | ANDA | Current |
| 72189-336 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Direct Rx | ANDA | Current |