FDA.reportPublic FDA data

Application 204041

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLMITRIPTANZOLMITRIPTANTABLET;ORAL2.5MGNoNo
002ZOLMITRIPTANZOLMITRIPTANTABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-021ZolmitriptanZolmitriptanAjanta Pharma USA Inc.ANDACurrent
27241-021ZolmitriptanZolmitriptanAjanta Pharma LimitedANDACurrent
27241-022ZolmitriptanZolmitriptanAjanta Pharma USA Inc.ANDACurrent
27241-022ZolmitriptanZolmitriptanAjanta Pharma LimitedANDACurrent
55700-943ZolmitriptanZolmitriptanQuality Care Products, LLCANDACurrent
55700-943ZolmitriptanZolmitriptanQuality Care Products, LLCANDACurrent
55700-943ZolmitriptanZolmitriptanQuality Care Products, LLCANDACurrent
55700-944ZolmitriptanZolmitriptanQuality Care Products, LLCANDACurrent
55700-944ZolmitriptanZolmitriptanQuality Care Products, LLCANDACurrent
55700-944ZolmitriptanZolmitriptanQuality Care Products, LLCANDACurrent