Registrants (1)
Aurobindo Pharma Limited
650082092
Manufacturing Establishments (2)
Aurobindo Pharma Limited
Rising Pharma Holdings, Inc.
Aurobindo Pharma Limited
650381903
APL HEALTHCARE LIMITED
Rising Pharma Holdings, Inc.
Aurobindo Pharma Limited
650918514
Products (2)
Valacyclovir Hydrochloride
57237-043
ANDA090682
ANDA (C73584)
ORAL
January 8, 2024
ValaciclovirActive
Code: G447S0T1VCClass: ACTIRQuantity: 1 g in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
Valacyclovir Hydrochloride
57237-042
ANDA090682
ANDA (C73584)
ORAL
January 8, 2024
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
ValaciclovirActive
Code: G447S0T1VCClass: ACTIRQuantity: 500 mg in 1 1
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MKClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT