FDA.reportPublic FDA data

Application 084285

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDECAPSULE;ORAL10MGNoYes

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
A084285-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALABRS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A084285-001AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A084285-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALABRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084285-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALABRS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A084285-001DICYCLOMINE HYDROCHLORIDE10MGCAPSULE / ORALABRS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A084285-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A084285-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A084285-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084285-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084285-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084285-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084285-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084285-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084285-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084285-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084285-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084285-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084285-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084285-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084285-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084285-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084285-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084285-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084285-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084285-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084285-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084285-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084285-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A084285-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084285-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084285-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084285-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A084285-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084285-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084285-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084285-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084285-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084285-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084285-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084285-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084285-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084285-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084285-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084285-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084285-001AB1f41ea6bd6efb…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEMajor Pharmaceuticals5eee0dff-d157-4534-adfb-c035b7042c072026-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 0904-6987
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECardinal Health 107, LLC793a3f0c-ea45-4e28-a98a-610cf9eddad82026-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 55154-3565
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDELannett Company, LLCbd2cba10-70ec-4d1f-b46c-53d1de2ee1302026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 0527-0586
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack4da6868f-3530-4960-af71-e56439c96e9f2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 71335-0471
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECardinal Health 107, LLC63b207da-159c-4cb5-8b06-616ed4811c122026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 55154-8183
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEProficient Rx LP3b7145d7-1ba7-45c1-8202-b8fc575d5a8e2025-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 63187-196
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEChartwell RX, LLCd628ac1c-404d-45eb-8aab-0e550c95ed4a2024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAmerican Health Packaging833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe82024-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 60687-369
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7c75f650-c97d-06fa-e053-2991aa0a43bb2024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 68071-3035
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEA-S Medication Solutionsb3c9dc85-2c6c-44f0-9c98-02673af934cb2024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 50090-0126
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEA-S Medication Solutions5f5d7145-118b-4cab-bfe0-19f7740ef1fe2023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 50090-0127
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC860e8ea6-6f9b-4fe6-a23d-3600b69c0b352019-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084285
application number: ANDA084285
ndc (product): 71610-265

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 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7384Dicyclomine HydrochlorideDicyclomine HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
0527-0586Dicyclomine HydrochlorideDicyclomine HydrochlorideLannett Company, Inc.ANDACurrent
0527-0586Dicyclomine HydrochlorideDicyclomine HydrochlorideLannett Company, Inc.ANDACurrent
0527-0586Dicyclomine HydrochlorideDicyclomine HydrochlorideLannett Company, Inc.ANDACurrent
0904-6987Dicyclomine HydrochlorideDicyclomine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6987Dicyclomine HydrochlorideDicyclomine HydrochlorideMajor PharmaceuticalsANDACurrent
10135-520Dicyclomine HydrochlorideDicyclomine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-520Dicyclomine HydrochlorideDicyclomine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
33261-963Dicyclomine HydrochlorideDicyclomine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
50090-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0126Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0127Dicyclomine HydrochlorideDicyclomine HydrochlorideA-S Medication SolutionsANDACurrent
53002-3291Dicyclomine HydrochlorideDicyclomine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
55154-3565Dicyclomine HydrochlorideDicyclomine HydrochlorideCardinal HealthANDACurrent
55154-3565Dicyclomine HydrochlorideDicyclomine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-8183Dicyclomine HydrochlorideDicyclomine HydrochlorideCardinal HealthANDACurrent
55154-8183Dicyclomine HydrochlorideDicyclomine HydrochlorideCardinal HealthANDACurrent
55154-8183Dicyclomine HydrochlorideDicyclomine HydrochlorideCardinal Health 107, LLCANDACurrent
60687-369Dicyclomine HydrochlorideDicyclomine HydrochlorideAmerican Health PackagingANDACurrent
60687-369Dicyclomine HydrochlorideDicyclomine HydrochlorideAmerican Health PackagingANDACurrent
60687-369Dicyclomine HydrochlorideDicyclomine HydrochlorideAmerican Health PackagingANDACurrent
60687-369Dicyclomine HydrochlorideDicyclomine HydrochlorideAmerican Health PackagingANDACurrent
63187-196Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63187-196Dicyclomine HydrochlorideDicyclomine HydrochlorideProficient Rx LPANDACurrent
63629-8049Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8049Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
64725-0586Dicyclomine HydrochlorideDicyclomine HydrochlorideTYA PharmaceuticalsANDACurrent
67296-1050Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1050Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1050Dicyclomine HydrochlorideDicyclomine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-3035Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3035Dicyclomine HydrochlorideDicyclomine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6937Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6937Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6937Dicyclomine HydrochlorideDicyclomine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0327Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0327Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0327Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0327Dicyclomine HydrochlorideDicyclomine HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0471Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0471Dicyclomine HydrochlorideDicyclomine HydrochlorideBryant Ranch PrepackANDACurrent
71610-265Dicyclomine HydrochlorideDicyclomine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent