PRIMAQUINE PHOSPHATE
PRIMAQUINE PHOSPHATE TABLETS, USP
Approved
Approval ID
82465385-4602-7f46-e053-2991aa0a9fdf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PRIMAQUINE PHOSPHATE
PRODUCT DETAILS
NDC Product Code42291-510
Application NumberANDA206043
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NamePRIMAQUINE PHOSPHATE
INGREDIENTS (10)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PRIMAQUINE PHOSPHATEActive
Quantity: 15 mg in 1 1
Code: H0982HF78B
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT