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 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
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
2026-09-14 22:38:342026-08A218310-001DICYCLOMINE HYDROCHLORIDE20MGTABLET / ORALAB2025-06-0684e616aacf4f…
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
2026-09-14 22:38:342026-08A218310-001AB184e616aacf4f…
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 2 of 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 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 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 HYDROCHLORIDEGolden State Medical Supply, Inc.05552560-6986-f9e8-e063-6394a90a4af02026-04-21Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack21ec88b3-22c7-492b-bfb1-73d3f98525222026-04-20Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEBryant Ranch Prepack5734fac5-893d-4afd-95a1-e7ab4fd1df3a2026-04-20Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.6fb9d156-f321-4f7d-b308-2a0e6056fd712026-04-06Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC66cf2cc1-6011-4879-8b25-8701b0677ac62026-03-09Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDENorthwind Health Company, LLC4dddbff3-2531-b35e-e063-6294a90a1d3b2026-03-06Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDESlate Run Pharmaceuticals, LLCe20a1ccf-2f3a-4872-811e-d93fb56b8e832026-03-04Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs3c1e31d4-c8b5-459e-9ada-2f1bae7fa2192026-02-26Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEAdvagen Pharma Ltd.,b4331e24-58af-45fb-a25b-9eb8270f83f72026-02-23Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEUpsher-Smith Laboratories, LLCceba627b-5fe2-4ab3-b3bc-d90c3a170a932026-02-23Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEA-S Medication Solutions2b33ef28-2b71-46c4-bb2f-694fefcd59ab2026-02-06Warnings, Adverse reactionsName fallback
brand name: Dicyclomine Hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.380270a8-d0a6-44cb-bb34-f91db6e6ac712026-01-27Warnings, Adverse reactionsName fallback
brand name: Dicyclomine hydrochloride
generic name: DICYCLOMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.