FDA.reportPublic FDA data

Application 207128

Type
ANDA
Sponsor
ECI PHARMS LLC

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 1.

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
A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE0.025MG;2.5MGTABLET / ORALAA2020-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207128-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-218869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207128-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGTABLET / ORALAA2020-10-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207128-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207128-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207128-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207128-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207128-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207128-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207128-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207128-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207128-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207128-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207128-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207128-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207128-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207128-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207128-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207128-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207128-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A207128-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207128-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207128-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A207128-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207128-001AA18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207128-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207128-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207128-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207128-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207128-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207128-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207128-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207128-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207128-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207128-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207128-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207128-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207128-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207128-001AA1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenoxylate hydrochloride and atropine sulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEChartwell RX, LLC240b537e-ff9b-45e3-9398-584372bd707a2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207128
application number: ANDA207128
ndc (product): 62135-618

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51293-618Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateECI Pharmaceuticals, LLCANDACurrent
51293-618Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateECI Pharmaceuticals, LLCANDACurrent
51293-618Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateECI Pharmaceuticals, LLCANDACurrent
62135-618Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and atropine sulfateChartwell RX, LLCANDACurrent
63629-9175Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9175Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9175Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9176Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9176Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent
63629-9176Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateBryant Ranch PrepackANDACurrent