FDA.reportPublic FDA data

Application 012649

Type
NDA
Sponsor
MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERIACTINCYPROHEPTADINE HYDROCHLORIDETABLET;ORAL4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N012649-001PERIACTINCYPROHEPTADINE HYDROCHLORIDE4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N012649-001PERIACTIN4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012649-001PERIACTIN4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012649-001PERIACTIN4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012649-001PERIACTIN4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDETRUPHARMA, LLC9c0b47c0-ecd2-450f-9dcb-c262db92866e2026-08-20Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepackdd2f3f0e-1bb8-432b-bcbb-01b4f550d0222026-08-17Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEAtlantic Biologicals Corp.582b86c6-f9b2-278d-e063-6394a90a923d2026-08-07Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDETRUPHARMA, LLC1d668d93-8c9e-479e-ad8d-59656c8dec1b2026-07-14Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEREMEDYREPACK INC.80411af3-03ee-4330-830b-f69f2a373ef92026-06-01Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEAtlantic Biological Corp.50b3abc0-d86a-e8f5-e063-6394a90ad25e2026-04-30Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEREMEDYREPACK INC.7b3aed50-cc9e-4897-9735-361225e9e5f22026-04-10Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEStrides Pharma Science Limitedb28c2ca0-140d-44d8-a59e-75fbfe8eabdd2026-03-06Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.03e69414-8a25-4ed8-b7ac-16445b879b1f2026-02-16Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.99fb821a-fe33-4468-9026-9729a8deff082026-01-22Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e2025-12-22Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEQPharma Incfc75bd79-63b7-6388-e053-6394a90ac3772025-12-02Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEQPharma Inc1dfe4478-76d9-9b8f-e063-6394a90aefe82025-12-01Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepack22eaef18-b5cc-421a-910e-d569f00b45992025-11-10Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEAvPAK426acecc-aef4-099c-e063-6294a90a54eb2025-10-30Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride solutionCYPROHEPTADINE HYDROCHLORIDEMethod Pharmaceuticals, LLC1acfd050-6c07-a269-e063-6394a90a77e82025-10-21Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEGolden State Medical Supply, Inc.95c03949-0e9a-e3b5-e053-2995a90a56b62025-08-06Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEBryant Ranch Prepack996dd4c6-ebcf-42e8-a950-9d34bb6f404f2025-05-05Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDERising Pharma Holdings, Inc.e2bf4d46-6585-41d9-868c-98603b165d5b2025-03-26Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDEIngenus Pharmaceuticals LLC56f428c9-8d33-4c91-91d8-1fe1943350662025-01-01Warnings, Adverse reactionsName fallback
generic name: CYPROHEPTADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20033SUPPL1999-09-24