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 5 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb96904e7-cc67-4abc-b946-8423f3f897ff2023-10-24Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc0a68671-407b-4840-9662-04f168cff1cb2023-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: promethazine hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd047b9a7c-586b-4635-a63e-2c7ce9ec34e72023-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC677b5fc5-94be-638b-e053-2991aa0a7f972023-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutions2c9a4767-23c4-4a1c-bb4c-2bad1351c2702023-05-08Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdc8b50de-e4f6-607f-e053-2995a90a29022023-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LPdcb1694a-8451-403c-b848-edb89ba170202023-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC32022e66-6f76-430a-8ad2-1e9e2872fee12023-02-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions87429921-00d2-42c7-9e99-600e8075b8ce2023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc930985b-bba3-4f3a-a1ae-1d808670efde2023-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LP59b906c6-2ccc-416e-b3ee-db09bf5531462023-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.ba7d9e82-9b13-4607-b2f9-25e575b8c73b2022-11-05Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProficient Rx LP29a8b172-1bad-40db-8d73-1fe7fb309cff2022-04-01Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LP08bf9fbf-cc21-41a0-9e81-ec498aa641702019-11-01Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEActavis Pharma, Inc.a32255f0-0077-489e-bdc6-869aca8cd4342016-12-01Warnings, 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