PRIMAQUINE PHOSPHATE
PRIMAQUINE PHOSPHATE TABLETS, USP
Approved
Approval ID
09531382-2e06-4164-a7e1-169a1488788a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2018
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-191
Application NumberANDA206043
Product Classification
M
Marketing Category
C73584
G
Generic Name
PRIMAQUINE PHOSPHATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2018
FDA Product Classification
INGREDIENTS (10)
PRIMAQUINE PHOSPHATEActive
Quantity: 15 mg in 1 1
Code: H0982HF78B
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
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
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT