FDA.reportPublic FDA data

Application 040713

Type
ANDA
Sponsor
KVK TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

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 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6bcaa89f-5f14-dc45-e053-2a91aa0aac542026-07-30Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECoupler LLC55f618d1-4466-3200-e063-6394a90a89a82026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.9e4e57fa-4ce3-4b7b-be5a-381801ed03862026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDESportpharm LLC4156e780-7ecf-bcae-e063-6394a90a2ae22026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEASCLEMED USA INC.4d30e587-6d59-4cf5-ab45-c7639f759df92026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEUnit Dose Solutions, Inc.5590f356-0904-58f6-e063-6294a90a6ad52026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.804e2525-d61f-7bed-e053-2991aa0a5daa2026-06-30Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacke6d940f8-fa1a-4a75-b4fc-2cbbaf7a04882026-06-05Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c472026-06-04Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5ce082e9-13eb-4e63-a9e2-657d3ef0e9f82026-05-22Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f93ca67d-362a-473f-8296-2952da77c0742026-05-22Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d2026-05-22Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEAtlantic Biologicals Corp.4f99bbd5-02f7-2fed-e063-6394a90a63552026-04-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsbf951b5b-6e38-44a9-895e-0d60c6b9d3432026-03-27Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.81fd29a9-c090-49ba-8b48-bd3656ca0c922026-03-19Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKVK-Tech, Inc.7a137adf-39b7-4b14-80da-c3cac9ad562a2026-03-13Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXbae9c9c1-107f-0fcb-e053-2a95a90a75b22026-03-05Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.7fa840ad-10e7-4faf-9325-4516486041612026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.adb04635-584f-4fef-98ca-2574be312a732026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell RX, LLC2ca17cd4-460e-4d54-8c53-a58a2b80e5cb2026-01-30Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE 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
60429-151PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent