FDA.reportPublic FDA data

Application 085762

Type
ANDA
Sponsor
MYLAN

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 44.

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
A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE0.025MG;2.5MGTABLET / ORALApproved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085762-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085762-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085762-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085762-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085762-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085762-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085762-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A085762-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085762-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085762-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085762-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A085762-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085762-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085762-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085762-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085762-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085762-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085762-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085762-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085762-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085762-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085762-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085762-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085762-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085762-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085762-001AA1cb3db0bc1861…

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0415Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0415Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateMylan Pharmaceuticals Inc.ANDACurrent
0615-7801Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-531Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateApotheca Inc.ANDACurrent
21695-688Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateRebel Distributors CorpANDACurrent
33261-685Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateAidarex Pharmaceuticals LLCANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0039Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
50090-0039Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
50090-0040Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateA-S Medication SolutionsANDACurrent
55289-102Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-102Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-102Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePD-Rx Pharmaceuticals, Inc.ANDACurrent
63187-254Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateProficient Rx LPANDACurrent
63187-254Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateProficient Rx LPANDACurrent
66267-082Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-082Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-780Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-780Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66336-437Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateDispensing Solutions, Inc.ANDACurrent
67296-0505Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateRedPharm Drug, Inc.ANDACurrent
67544-021Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-9135Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0919Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateREMEDYREPACK INC.ANDACurrent
70518-0919Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateREMEDYREPACK INC.ANDACurrent