FDA.reportPublic FDA data

Application 040583

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 40MG BASE/VIALNoNo
002METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 125MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55154-9383Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATECardinal HealthANDACurrent
55154-9557Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATECardinal HealthANDACurrent
63323-255Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEFresenius Kabi USA, LLCANDACurrent
63323-255Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEFresenius Kabi USA, LLCANDACurrent
63323-255Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEFresenius Kabi USA, LLCANDACurrent
63323-258Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEFresenius Kabi USA, LLCANDACurrent
63323-258Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEFresenius Kabi USA, LLCANDACurrent
63323-258Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEFresenius Kabi USA, LLCANDACurrent
70518-2942Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.ANDACurrent
70518-3128Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42632ORIG2007-07-06
7673ORIG2004-08-02