FDA.reportPublic FDA data

Application 088158

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPROMAZINE HYDROCHLORIDE INTENSOLCHLORPROMAZINE HYDROCHLORIDECONCENTRATE;ORAL100MG/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
A088158-001CHLORPROMAZINE HYDROCHLORIDE INTENSOLCHLORPROMAZINE HYDROCHLORIDE100MG/MLCONCENTRATE / ORAL1983-04-27

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 UTC2022-09A088158-001CHLORPROMAZINE HYDROCHLORIDE INTENSOL100MG/MLCONCENTRATE / ORAL1983-04-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088158-001CHLORPROMAZINE HYDROCHLORIDE INTENSOL100MG/MLCONCENTRATE / ORAL1983-04-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088158-001CHLORPROMAZINE HYDROCHLORIDE INTENSOL100MG/MLCONCENTRATE / ORAL1983-04-27a50c72e98297…

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 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.9709ffde-7034-42be-97be-f5f39eeacf722026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.d1d8fd92-bba6-4521-8cea-3e1089ffd9512026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.a2ca3aa1-9e3b-4eca-af26-165562cee7bc2026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDENorthstar Rx LLC2bd42d3a-bf89-4d74-a252-9b914106a5702026-08-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.41b86f9d-d7e2-4296-8d88-e8257c7cbed22026-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.2122d619-3f5b-48f6-8f0b-7693199abbdb2026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEAmerican Health Packaging85ab0b93-c716-4889-87db-9e76e75df7c72026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEAurobindo Pharma Limitedc2a8b8a3-187f-4000-bde3-b40bb0e5600f2026-05-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAmneal Pharmaceuticals NY LLCaa086a21-de85-4b03-af58-49b70acf8cf02026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.d3b09b67-e8da-450d-8a52-b3c40605de262026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.b8137906-946c-455d-87c0-0e130cd9266f2026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDESaptalis Pharmaceuticals, LLC.cd8f9e23-d08a-4d96-8fe9-35ab2bc861c82026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC5ae79c1e-f523-4358-9f8b-7382a03d59bc2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEREMEDYREPACK INC.c2a38be8-43e6-4a56-9556-fe3dad412b822026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDENovadoz Pharmaceuticals LLCc0c5f94c-5f4d-43db-8cc2-ffc8a45b64cf2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEAvPAK9e8cebc0-7fcf-dca8-e053-2a95a90a33692026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDECoupler LLC472e9a45-4060-3b2a-e063-6294a90a716a2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
Chlorpromazine HydrochlorideCHLORPROMAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.c212a2a1-323a-8b61-e053-2995a90a5b042025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochlorideCHLORPROMAZINE HYDROCHLORIDEChartwell RX, LLCe9d6a9e9-ba25-4c25-9b03-25897a3ac5f32025-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDEEugia US LLC07e6144a-b460-4887-b8e2-dd371c14a55c2025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CHLORPROMAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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