FDA.reportPublic FDA data

Application 218310

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A218310-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB2025-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218310-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A218310-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB2025-06-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218310-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB2025-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218310-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB2025-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218310-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB2025-06-066a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218310-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB2025-06-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A218310-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218310-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218310-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218310-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218310-001AB1a50c72e98297…

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 6 · 119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.7ff96d1f-fb87-4244-a697-1d93e10eb7382026-08-21Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug594b6832-a31c-4de2-e063-6294a90a05fa2026-08-18Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.2c36b79f-153c-446c-899b-6e28ccff1dc82026-08-18Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug58e713f9-6412-0a1a-e063-6394a90a91b62026-08-13Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECardinal Health 107, LLC793a3f0c-ea45-4e28-a98a-610cf9eddad82026-08-12Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9d249073-0171-4bb0-8cad-13cb3713159f2026-08-12Warnings, Adverse reactionsName fallback
brand name: DICYCLOMINE HYDROCHLORIDE
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.de44e605-14a3-4b40-bf1b-2ac857eb7b122026-08-12Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDELannett Company, LLCbd2cba10-70ec-4d1f-b46c-53d1de2ee1302026-08-06Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug57e5f041-9a6e-9d0c-e063-6294a90ab54c2026-07-31Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
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 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