FDA.reportPublic FDA data

Application 087844

Type
ANDA
Sponsor
MALLINCKRODT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOFRANILIMIPRAMINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.830cb1cb-20a1-4617-a748-24241257a2442026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.02c19a0a-3d9d-4881-ad14-1687aafd87b52026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEStrides Pharma Science Limited51d3b181-0d15-4782-a966-feb137972b182026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEA-S Medication Solutionsd9dbcebe-9aba-4a93-a7b7-48d29e07d3c42026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7091ff32-55b9-48fd-a86d-c502af57473f2026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.649837df-147f-436c-9553-32ffecf4c6f12026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepackbcd3b62a-88d4-49eb-b0aa-71e28cf409192026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEOxford Pharmaceuticals, LLCa5f60cf1-6f14-40a3-a794-9d69b28088d82026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.db007ac0-020e-4962-8903-7497ab96a74e2026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDECoupler LLC48e8b819-a9a0-aa5a-e063-6394a90ad9c22026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP5997822f-ce83-4091-be71-21a6b01caaba2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELeading Pharma, LLC490263ce-b4d2-428a-87da-fcd07f85499a2025-12-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepack20af582f-08ba-4281-a2df-0bcf68c585942025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine hydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf887062a-7c82-664f-e053-6294a90a27732024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCfd78fb8e-99ae-91b0-e053-6394a90a92712024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEKey Therapeutics9c685c94-64cd-442a-ade7-193c62d7a0582024-10-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.209cc339-658a-577a-e063-6394a90a2b472024-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELupin Pharmaceuticals, Inc.55311747-710c-43c4-821d-76323ff2520e2023-12-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP3f90b8dd-7234-4428-b896-943d052dd05f2023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IMIPRAMINE HYDROCHLORIDE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69874-992TofranilImipramine hydrochlorideThompson Medical Solutions LLCANDACurrent