MedPath
FDA Approval

Fluoxetine Hydrochloride

August 8, 2023

HUMAN PRESCRIPTION DRUG LABEL

Fluoxetine(20 mg in 1 1)

Products (2)

Fluoxetine Hydrochloride

0832-0403

ANDA211696

ANDA (C73584)

ORAL

June 30, 2023

Code: I9W7N6B1KJClass: ACTIMQuantity: 20 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT

Fluoxetine Hydrochloride

0832-0402

ANDA211696

ANDA (C73584)

ORAL

June 30, 2023

Code: I9W7N6B1KJClass: ACTIMQuantity: 10 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
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