Registrants (1)
TIME CAP LABORATORIES, INC.
037052099
Manufacturing Establishments (1)
MARKSANS PHARMA LIMITED
TIME CAP LABORATORIES, INC.
TIME CAP LABORATORIES, INC.
925822975
Products (2)
Valacyclovir Hydrochloride
49483-690
ANDA079012
ANDA (C73584)
ORAL
July 17, 2021
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ValaciclovirActive
Code: G447S0T1VCClass: ACTIRQuantity: 500 mg in 1 1
Valacyclovir Hydrochloride
49483-691
ANDA079012
ANDA (C73584)
ORAL
July 17, 2021
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
ValaciclovirActive
Code: G447S0T1VCClass: ACTIRQuantity: 1 g in 1 1