FDA.report

Application 040646

Type
ANDA
Sponsor
IMPAX LABS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONEHYDROCORTISONETABLET;ORAL5MGNoNo
002HYDROCORTISONEHYDROCORTISONETABLET;ORAL10MGNoNo
003HYDROCORTISONEHYDROCORTISONETABLET;ORAL20MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1696HYDROCORTISONEhydrocortisoneAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1696HYDROCORTISONEhydrocortisoneAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1696HYDROCORTISONEhydrocortisoneImpax GenericsANDACurrent
0115-1697HYDROCORTISONEhydrocortisoneImpax GenericsANDACurrent
0115-1697HYDROCORTISONEhydrocortisoneAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1697HYDROCORTISONEhydrocortisoneAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1700HYDROCORTISONEhydrocortisoneImpax GenericsANDACurrent
0115-1700HYDROCORTISONEhydrocortisoneAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1700HYDROCORTISONEhydrocortisoneAmneal Pharmaceuticals of New York LLCANDACurrent
0904-7188HYDROCORTISONEhydrocortisoneMajor PharmaceuticalsANDACurrent
54505-331HYDROCORTISONEhydrocortisoneLineage Therapeutics IncANDACurrent
54505-332HYDROCORTISONEhydrocortisoneLineage Therapeutics IncANDACurrent
54505-333HYDROCORTISONEhydrocortisoneLineage Therapeutics IncANDACurrent
63629-7241HYDROCORTISONEhydrocortisoneBryant Ranch PrepackANDACurrent
68151-2269HYDROCORTISONEhydrocortisoneCarilion Materials ManagementANDACurrent
71335-1989HYDROCORTISONEhydrocortisoneBryant Ranch PrepackANDACurrent
71335-2044HYDROCORTISONEhydrocortisoneBryant Ranch PrepackANDACurrent
71335-2044HYDROCORTISONEhydrocortisoneBryant Ranch PrepackANDACurrent