FDA.reportPublic FDA data

Application 086727

Type
ANDA
Sponsor
ANI PHARMS INC

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
A086727-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE0.025MG;2.5MGTABLET / ORALAAApproved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A086727-001AA

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 UTC2022-10A086727-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086727-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086727-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A086727-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAAApproved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A086727-001AA1c2088c7a36db…
2026-09-14 22:38:342026-08A086727-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A086727-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A086727-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A086727-001AA131067a03dcf5…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086727-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086727-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086727-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086727-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086727-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086727-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086727-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A086727-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086727-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086727-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086727-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A086727-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A086727-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A086727-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A086727-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A086727-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A086727-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A086727-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A086727-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A086727-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A086727-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A086727-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A086727-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A086727-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086727-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086727-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A086727-001AA1a50c72e98297…

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 1 · 6 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 reactionsExact identifier
application applno (ANDA): 086727
application number: ANDA086727
ndc (product): 50090-3456
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackbd08ed90-dd26-4629-83c0-0f75af6ebb952026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086727
application number: ANDA086727
ndc (product): 71335-0311
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEANI Pharmaceuticals, Inc.73dc5f91-d562-44c5-a556-66c96ed1dd822025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086727
application number: ANDA086727
ndc (product): 62559-490
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATENuCare Pharmaceuticals,Inc.575c38b4-7ec0-6d25-e053-2a91aa0a80fc2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086727
application number: ANDA086727
ndc (product): 68071-4063
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEProficient Rx LPc832ef16-a06e-4e47-9df3-ab33bdfa6e562020-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086727
application number: ANDA086727
ndc (product): 63187-939
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLC435e5e75-5a4c-4806-8d9e-d4be3fef92292017-08-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086727
application number: ANDA086727
ndc (product): 43353-594

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43353-594Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3452Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3452Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3456Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3456Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
50090-3456Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateA-S Medication SolutionsANDACurrent
53002-3400Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53002-3400Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRPK Pharmaceuticals, Inc.ANDACurrent
61919-405DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIRECT RXANDACurrent
61919-405DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect_RxANDACurrent
61919-405DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDirect_RxANDACurrent
62559-490Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateANI Pharmaceuticals, Inc.ANDACurrent
62559-490Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateANI Pharmaceuticals, Inc.ANDACurrent
63187-939Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateProficient Rx LPANDACurrent
63187-939Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateProficient Rx LPANDACurrent
63187-939Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateProficient Rx LPANDACurrent
63629-1933Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-1933Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-1934Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-1934Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
67296-1572Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateRedPharm Drug, Inc.ANDACurrent
68071-4063Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4063Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4063Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfatePreferred Pharmaceuticals Inc.ANDACurrent
70518-3513Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.ANDACurrent
70518-3513Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateREMEDYREPACK INC.ANDACurrent
71335-0311Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
71335-0311Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent