FDA.reportPublic FDA data

Application 207549

Type
ANDA
Sponsor
AMNEAL

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
70121-1000Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent
70121-1000Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent
70121-1000Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent
70121-1000Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Biosciences LLCANDACurrent
70121-1000Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent
70121-1001Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent
70121-1001Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent
70121-1001Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent
70121-1001Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Biosciences LLCANDACurrent
70121-1001Methylprednisolone Sodium SuccinateMethylprednisoloneAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47112ORIG2017-02-07
46025ORIG2016-12-06