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 4 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.84899861-8fed-536d-e053-2991aa0a42b22024-09-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsa4fbc2d8-19b3-4556-b0b9-6e7a14cd4c362024-09-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepack07914b6e-c40f-44be-a1db-8724c70f99b62024-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackea490539-007b-47b1-bef9-22de02ae7c642024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacka4b3da5b-1129-43c2-bf22-3a29c3fae1162024-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8749824b-6d66-430d-e053-2995a90a2db82024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7e5715cf-056f-4095-e053-2991aa0ad3e52024-06-12Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.4bf3912c-8339-401e-9711-dad6acf15f112024-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.481866da-a712-48a5-853f-8e84aacaab6d2024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b0d5abba-6fae-4f3c-b990-dd9c83c7b5a92024-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.365138a6-28d8-4881-a3e9-02c80aaf83e82024-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackda246971-20b8-b46e-8366-9700d3604cf12024-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.b4985d9d-1aa0-4b36-bc98-6a5410ad9bad2024-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.b6f6698f-f23c-452a-9b38-bbb96ab88ae42024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.1d02d52b-84bb-4e81-b352-125029eb39f62024-01-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsa7b1e8b2-6f20-4096-87c7-cf349ed4f7b92023-12-15Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb54439a3-1d01-4c5f-8508-731790ae215b2023-12-15Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHEGANPROMETHAZINE HYDROCHLORIDECosette Pharmaceuticals, Inc.5f079815-f48b-8b21-2130-7f791d967c9a2023-11-30Boxed warning, Adverse reactionsName fallback
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHEGANPROMETHAZINE HYDROCHLORIDECosette Pharmaceuticals, Inc.636bb9bc-0cc5-4d6a-85be-6471acf01ffc2023-11-30Boxed warning, Adverse reactionsName fallback
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.c0c0d4f0-8396-485b-a585-71df01491f6f2023-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

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