FDA.reportPublic FDA data

Application 210788

Type
ANDA
Sponsor
CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoNo

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
A210788-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MG/MLINJECTABLE / INJECTION2019-02-11

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
2026-08-01 22:54:322026-06A210788-001DICYCLOMINE HYDROCHLORIDE10MG/MLINJECTABLE / INJECTION2019-02-11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEAdvagen Pharma Ltd.,a66aa5c7-1fde-42fc-9e1f-7f4cc9adac9c2026-07-22Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack3dc0f4f0-ee38-4f9b-abb6-6395215fe5242026-07-16Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack4da6868f-3530-4960-af71-e56439c96e9f2026-07-14Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack34db5a80-f445-41e5-b3c4-4c18abb09c922026-07-14Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.7ff96d1f-fb87-4244-a697-1d93e10eb7382026-07-10Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy41aed1c9-b32f-3694-e063-6394a90a29e42026-06-25Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEAvPAK141d3818-7a87-aaa0-e063-6294a90a48662026-06-23Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy1b2d5256-b75d-11f8-e063-6394a90ae9ed2026-06-23Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy2ad04535-1c34-6c5c-e063-6294a90a0c172026-06-19Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEMajor Pharmaceuticals5eee0dff-d157-4534-adfb-c035b7042c072026-06-16Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.53e8777d-d54f-a9da-e063-6294a90a16082026-06-10Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEUnit Dose Solutions, Inc.5370e633-53a3-3764-e063-6394a90a3cad2026-06-04Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDELannett Company, Inc.bd2cba10-70ec-4d1f-b46c-53d1de2ee1302026-06-01Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEPar Health USA, LLCbb099db9-f635-4a64-8892-6236971dec452026-05-08Warnings, Adverse reactionsName fallback
brand name: dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECardinal Health 107, LLC63b207da-159c-4cb5-8b06-616ed4811c122026-05-05Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.400ac94f-2cf6-bd52-e063-6294a90a4f052026-05-04Warnings, Adverse reactionsName fallback
brand name: DICYCLOMINE HYDROCHLORIDE
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECoupler LLC508a7d45-4efd-8532-e063-6294a90a77412026-04-28Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECoupler LLC5025a55d-ff55-c810-e063-6294a90adfb32026-04-23Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECardinal Health 107, LLC793a3f0c-ea45-4e28-a98a-610cf9eddad82026-04-22Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEGolden State Medical Supply, Inc.05552560-6986-f9e8-e063-6394a90a4af02026-04-21Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24201-585Dicyclomine HydrochlorideDicyclomine Hydrochloride InjectionLeucadia Pharmaceuticals, Inc.ANDACurrent
24201-585Dicyclomine HydrochlorideDicyclomine Hydrochloride InjectionLeucadia Pharmaceuticals, Inc.ANDACurrent
24201-585Dicyclomine HydrochlorideDicyclomine Hydrochloride InjectionLeucadia PharmaceuticalsANDACurrent