FDA.reportPublic FDA data

Application 040650

Type
ANDA
Sponsor
VINTAGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE WITH CODEINECODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDESYRUP;ORAL10MG/5ML;6.25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0928Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphatePharmaceutical Associates, Inc.ANDACurrent
0121-0928Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphatePharmaceutical Associates, Inc.ANDACurrent
0603-1585Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphatePar PharmaceuticalANDACurrent
0603-1585Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphatePar PharmaceuticalANDACurrent
17856-1585Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateAtlantic Biologicals CorpsANDACurrent
21695-336Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateRebel Distributors CorpANDACurrent
33261-391Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateAidarex Pharmaceuticals LLCANDACurrent
49999-152Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50436-1029Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateUnit Dose ServicesANDACurrent
53002-3270Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateRPK Pharmaceuticals, Inc.ANDACurrent
53002-3270Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateRPK Pharmaceuticals, Inc.ANDACurrent
63187-271Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateProficient Rx LPANDACurrent
63187-271Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateProficient Rx LPANDACurrent
68071-1606Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4037Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9895Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphatePreferred Pharmaceuticals, IncANDACurrent
68788-9895Promethazine with CodeinePromethazine Hydrochloride and Codeine PhosphatePreferred Pharmaceuticals, IncANDACurrent