MedPath
FDA Approval

Valacyclovir Hydrochloride

January 8, 2024

Human Prescription Drug Label

Valaciclovir(1 g in 1 1)

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

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
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
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