FDA.reportPublic FDA data

Application 086765

Type
ANDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDECONCENTRATE;ORAL25MG/MLNoNo

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
A086765-001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE25MG/MLCONCENTRATE / ORALApproved 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A086765-001IMIPRAMINE HYDROCHLORIDE25MG/MLCONCENTRATE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086765-001IMIPRAMINE HYDROCHLORIDE25MG/MLCONCENTRATE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A086765-001IMIPRAMINE HYDROCHLORIDE25MG/MLCONCENTRATE / ORALApproved 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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELeading Pharma, LLC490263ce-b4d2-428a-87da-fcd07f85499a2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.830cb1cb-20a1-4617-a748-24241257a2442026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEREMEDYREPACK INC.02c19a0a-3d9d-4881-ad14-1687aafd87b52026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEStrides Pharma Science Limited51d3b181-0d15-4782-a966-feb137972b182026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEA-S Medication Solutionsd9dbcebe-9aba-4a93-a7b7-48d29e07d3c42026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepackbcd3b62a-88d4-49eb-b0aa-71e28cf409192026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEOxford Pharmaceuticals, LLCa5f60cf1-6f14-40a3-a794-9d69b28088d82026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDECoupler LLC48e8b819-a9a0-aa5a-e063-6394a90ad9c22026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP5997822f-ce83-4091-be71-21a6b01caaba2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEBryant Ranch Prepack20af582f-08ba-4281-a2df-0bcf68c585942025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine hydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf887062a-7c82-664f-e053-6294a90a27732024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCfd78fb8e-99ae-91b0-e053-6394a90a92712024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEKey Therapeutics9c685c94-64cd-442a-ade7-193c62d7a0582024-10-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.209cc339-658a-577a-e063-6394a90a2b472024-08-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDELupin Pharmaceuticals, Inc.55311747-710c-43c4-821d-76323ff2520e2023-12-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEProficient Rx LP3f90b8dd-7234-4428-b896-943d052dd05f2023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Imipramine Hydrochloride
generic name: IMIPRAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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