FDA.reportPublic FDA data

Application 212396

Type
ANDA
Sponsor
GENEYORK PHARMS

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
003METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
004METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
005METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 2GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-127Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-127Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-128Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-128Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-129Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-129Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-130Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
43598-130Methylprednisolone sodium succinateMethylprednisolone sodium succinateDr. Reddy's Laboratories IncANDACurrent
71329-301Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-302Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-303Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-304Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
71329-305Methylprednisolone Sodium SuccinateMethylprednisoloneGeneYork Pharmaceuticals Group LLCANDACurrent
82094-401Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-401Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-402Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-402Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-403Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-403Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-404Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-404Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-405Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent
82094-405Methylprednisolone Sodium SuccinateMethylprednisoloneTianjin Kingyork Pharmaceuticals Co., LtdANDACurrent