Registrants (1)
Zydus Lifesciences Limited
918596198
Manufacturing Establishments (1)
Zydus Lifesciences Limited
Zydus Lifesciences Limited
Zydus Lifesciences Limited
863362789
Products (2)
Eletriptan hydrobromide
70771-1107
ANDA206409
ANDA (C73584)
ORAL
August 25, 2022
EletriptanActive
Code: M41W832TA3Class: ACTIMQuantity: 20 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Eletriptan hydrobromide
70771-1108
ANDA206409
ANDA (C73584)
ORAL
August 25, 2022
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
EletriptanActive
Code: M41W832TA3Class: ACTIMQuantity: 40 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT