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 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
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 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 22:38:342026-08A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085762-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982f41ea6bd6efb…

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATELeading Pharma, LLC1c188bc9-7c21-4717-94a0-cdfb581fb7762023-02-15Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutions24077113-11b2-4cde-afa7-1a1e364173c22023-02-06Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEWinder Laboratories LLC7344a2d2-1f8a-4c5a-90e3-181b919c0c7a2022-05-31Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEProficient Rx LP593f2d01-5d24-450e-a6cf-204b7420f9712022-03-01Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEProficient Rx LPc832ef16-a06e-4e47-9df3-ab33bdfa6e562020-03-01Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLC435e5e75-5a4c-4806-8d9e-d4be3fef92292017-08-31Warnings, Adverse reactionsName fallback
brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLC59934cee-4e1f-4958-9e97-6de53b39daf32016-06-10Warnings, 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