FDA.reportPublic FDA data

Application 209718

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBAZAMCLOBAZAMTABLET;ORAL10MGNoNo
002CLOBAZAMCLOBAZAMTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-423ClobazamClobazamAmerican Health PackagingANDACurrent
60687-423ClobazamClobazamAmerican Health PackagingANDACurrent
60687-423ClobazamClobazamAmerican Health PackagingANDACurrent
60687-423ClobazamClobazamAmerican Health PackagingANDACurrent
60687-423ClobazamClobazamAmerican Health PackagingANDACurrent
69238-1305CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1305CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1305CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1305CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1305CLOBAZAMCLOBAZAMAmneal Pharmaceuticals LLCANDACurrent
69238-1306CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1306CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1306CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1306CLOBAZAMCLOBAZAMAmneal Pharmaceuticals NY LLCANDACurrent
69238-1306CLOBAZAMCLOBAZAMAmneal Pharmaceuticals LLCANDACurrent