Registrants (1)
Jubilant Generics Limited
650801538
Manufacturing Establishments (1)
Jubilant Generics Limited
Jubilant Cadista Pharmaceuticals Inc.
Jubilant Generics Limited
650369221
Products (2)
Zolmitriptan OD
59746-462
ANDA202956
ANDA (C73584)
ORAL
December 30, 2019
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
ZolmitriptanActive
Code: 2FS66TH3YWClass: ACTIBQuantity: 5 mg in 1 1
Magnesium Aluminum Silicate Type IaInactive
Code: SUS08ZOA9SClass: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141JClass: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14Class: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIHClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
MannitolInactive
Code: 3OWL53L36AClass: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9Class: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
PeppermintInactive
Code: V95R5KMY2BClass: IACT
Zolmitriptan OD
59746-461
ANDA202956
ANDA (C73584)
ORAL
December 30, 2019
Magnesium Aluminometasilicate Type I-aInactive
Code: 7LVU907546Class: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141JClass: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4Class: IACT
ZolmitriptanActive
Code: 2FS66TH3YWClass: ACTIBQuantity: 2.5 mg in 1 1
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14Class: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIHClass: IACT
TalcInactive
Code: 7SEV7J4R1UClass: IACT
MannitolInactive
Code: 3OWL53L36AClass: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9Class: IACT
Magnesium StearateInactive
Code: 70097M6I30Class: IACT
PeppermintInactive
Code: V95R5KMY2BClass: IACT