FDA.reportPublic FDA data

Application 087165

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHEGANPROMETHAZINE HYDROCHLORIDESUPPOSITORY;RECTAL50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0132PROMETHEGANpromethazine hydrochlorideG&W Laboratories, Inc.ANDACurrent
0713-0132PROMETHEGANpromethazine hydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0132PROMETHEGANpromethazine hydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
0713-0132PROMETHEGANpromethazine hydrochlorideCosette Pharmaceuticals, Inc.ANDACurrent
40085-220Promethazine HydrochloridePromethazine HydrochlorideRenaissance Pharma, Inc.ANDACurrent
40085-220Promethazine HydrochloridePromethazine HydrochlorideRenaissance Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43204ORIG2011-05-06