FDA.reportPublic FDA data

Application 084176

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoYes
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo
003PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1830Promethazine HydrochloridePromethazine HydrochlorideSandoz IncANDACurrent
0781-1830Promethazine HydrochloridePromethazine HydrochlorideSandoz IncANDACurrent
0781-1830Promethazine HydrochloridePromethazine HydrochlorideSandoz IncANDACurrent
0781-1832Promethazine HydrochloridePromethazine HydrochlorideSandoz IncANDACurrent
0781-1832Promethazine HydrochloridePromethazine HydrochlorideSandoz IncANDACurrent
0781-1832Promethazine HydrochloridePromethazine HydrochlorideSandoz IncANDACurrent
0904-6461Promethazine HydrochloridePromethazine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6461Promethazine HydrochloridePromethazine HydrochlorideMajor PharmaceuticalsANDACurrent
50090-2906Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3077Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
55154-8080Promethazine HydrochloridePromethazine HydrochlorideCardinal HealthANDACurrent
55154-8080Promethazine HydrochloridePromethazine HydrochlorideCardinal HealthANDACurrent
55154-8080Promethazine HydrochloridePromethazine HydrochlorideCardinal Health 107, LLCANDACurrent
63739-213Promethazine HydrochloridePromethazine HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent
63739-213Promethazine HydrochloridePromethazine HydrochlorideMcKesson Corporation dba SKY PackagingANDACurrent