FDA.reportPublic FDA data

Application 040712

Type
ANDA
Sponsor
KVK TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo
003PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-8195Promethazine HydrochloridePromethazine HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
10544-051PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10702-002PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideKVK-Tech, Inc.ANDACurrent
10702-002PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideKVK-Tech, Inc.ANDACurrent
10702-003PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideKVK-Tech, Inc.ANDACurrent
10702-003PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideKVK-Tech, Inc.ANDACurrent
10702-004PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideKVK-Tech, Inc.ANDACurrent
10702-004PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideKVK-Tech, Inc.ANDACurrent
33261-131Promethazine HydrochloridePromethazine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-865Promethazine HydrochloridePromethazine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-874PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-875PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-875PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-875PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-875PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-875PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-875PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-875PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-876PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-876PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-876PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-876PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-592PROMETHAZINE HYDROCHLORIDEpromethazine hydrochloridemedsource pharmaceuticalsANDACurrent
50090-4452PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4453PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4453PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4453PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4608PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4750PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50090-4750PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideA-S Medication SolutionsANDACurrent
50436-4379PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideUnit Dose ServicesANDACurrent
53002-4020PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-4020PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53808-0546Promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEState of Florida DOH Central PharmacyANDACurrent
54348-117PromethazinePROMETHAZINEPharmPak, Inc.ANDACurrent
54348-117PromethazinePROMETHAZINEPharmPak, Inc.ANDACurrent
55700-221PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-221PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-221PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-221PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-221PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideQuality Care Products LLCANDACurrent
55700-221PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-690PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-690PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-690PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-149PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-149PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-149PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-149PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-149PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-150PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent
60429-150PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-150PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-150PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-150PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-150PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-151PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-151PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-151PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-151PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-151PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63629-7670PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideBryant Ranch PrepackANDACurrent
63629-7670PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideBryant Ranch PrepackANDACurrent
63629-7670PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideBryant Ranch PrepackANDACurrent
67296-0564PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-0564PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
67296-0564PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDERedPharm Drug, Inc.ANDACurrent
68071-4424PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4424PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4686PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4686PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4737PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4737PROMETHAZINE HYDROCHLORIDEpromethazine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29963ORIG2006-08-11