FDA.reportPublic FDA data

Application 040428

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDESUPPOSITORY;RECTAL25MGNoYes
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDESUPPOSITORY;RECTAL12.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2985PHENADOZPromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2985PHENADOZPromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2985PHENADOZPromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2992PHENADOZPromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2992PHENADOZPromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0591-2992PHENADOZPromethazine HydrochlorideActavis Pharma, Inc.ANDACurrent
0713-0526PROMETHEGANPromethazine HydrochlorideG&W Laboratories, Inc.ANDACurrent
0713-0526PROMETHEGANPromethazine HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0526PROMETHEGANPromethazine HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0526PROMETHEGANPromethazine HydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0536PROMETHEGANpromethazine hydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0536PROMETHEGANpromethazine hydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0536PROMETHEGANpromethazine hydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0536PROMETHEGANpromethazine hydrochlorideG&W Laboratories, Inc.ANDACurrent
21695-959Prometheganpromethazine hydrochlorideRebel Distributors CorpANDACurrent
40085-218Promethazine HydrochloridePromethazine HydrochlorideRenaissance Pharma, Inc.ANDACurrent
40085-218Promethazine HydrochloridePromethazine HydrochlorideRenaissance Pharma, Inc.ANDACurrent
40085-219Promethazine HydrochloridePromethazine HydrochlorideRenaissance Pharma, Inc.ANDACurrent
40085-219Promethazine HydrochloridePromethazine HydrochlorideRenaissance Pharma, Inc.ANDACurrent
43063-376Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-376Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-376Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-708PromethazinePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-708PromethazinePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-708PromethazinePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1575PROMETHEGANPromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3894PHENADOZPromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3894PHENADOZPromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3894PHENADOZPromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3894PHENADOZPromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3897PHENADOZPromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3897PHENADOZPromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5362Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5362Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
51672-5296Promethazine HydrochloridePromethazine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-5296Promethazine HydrochloridePromethazine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-5297Promethazine HydrochloridePromethazine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-5297Promethazine HydrochloridePromethazine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
52959-731PROMETHEGANPROMETHAZINE HYDROCHLORIDEH.J. Harkins Company, Inc.ANDACurrent
55289-928PROMETHEGANPromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-928PROMETHEGANPromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-928PROMETHEGANPromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-928PROMETHEGANPromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-928PROMETHEGANPromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-928PROMETHEGANPromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-928PROMETHEGANPromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
68071-3254Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22140ORIG2004-12-08