FDA.reportPublic FDA data

Application 087195

Type
ANDA
Sponsor
VALEANT PHARM INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDETABLET;ORAL0.025MG;2.5MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE0.025MG;2.5MGTABLET / ORAL1982-02-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-1684e616aacf4f…
2026-08-18 06:07:402026-07A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-163f01610625f2…
2019-09-15 20:21 UTC2019-09A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087195-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORAL1982-02-16f41ea6bd6efb…

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 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutionsf94a0189-40d2-42e0-8d2b-c9dc433faad12026-07-29Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEREMEDYREPACK INC.3d0e2877-7a74-433f-8a31-e3e54aa9dc9f2026-06-10Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERedpharm Drug5342df5c-12bb-565c-e063-6294a90a4ade2026-06-02Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackbd08ed90-dd26-4629-83c0-0f75af6ebb952026-05-21Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPreferred Pharmaceuticals Inc.46d5b27b-a710-4767-b308-4f673ddb354c2026-04-06Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEMylan Pharmaceuticals Inc.83bcc2fb-6fb0-4f0e-8e66-592d327684ec2026-02-23Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEANI Pharmaceuticals, Inc.73dc5f91-d562-44c5-a556-66c96ed1dd822025-12-22Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEUnichem Pharmaceuticals (USA), Inc.5117f26c-488f-4ba6-b115-22baf12557f32025-12-11Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate hydrochloride and atropine sulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEChartwell RX, LLC240b537e-ff9b-45e3-9398-584372bd707a2025-12-10Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate hydrochloride and atropine sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAmerican Health Packagingd0a1c80d-6aae-4886-8c25-e2d29ca0836b2025-07-30Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHikma Pharmaceuticals USA Inc.88ed4ccf-9e35-4142-a5eb-d2b5edd369562025-06-26Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPD-Rx Pharmaceuticals, Inc.700aad61-fa8c-4ded-87b8-da966093075a2025-04-17Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERedpharm Drug Inc.f4c35a82-5927-5bc2-e053-2a95a90aea4d2025-01-23Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect Rxd9a36478-4788-4107-e053-2a95a90ad6da2025-01-21Adverse reactionsName fallback
brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutions1be4dd7d-766c-4b3c-8b86-4f219ab447262024-11-13Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackb3f58de9-1cc8-4bc5-842f-010cc48d35822024-08-23Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATENuCare Pharmaceuticals,Inc.575c38b4-7ec0-6d25-e053-2a91aa0a80fc2024-07-18Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLC14bf7191-580f-76dc-e063-6294a90aed2a2024-04-08Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATESpecGx LLC24915aa0-1600-44bb-99fc-46529a7941242023-06-27Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLCc11574c7-8344-4987-85ef-f2404daa08852023-06-13Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.