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Allopurinol

Approved
Approval ID

ae821c68-626a-474c-b81d-ce75d9795b3c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 15, 2016

Manufacturers
FDA

Aphena Pharma Solutions - Tennessee, LLC

DUNS: 128385585

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

allopurinol

PRODUCT DETAILS

NDC Product Code67544-736
Application NumberANDA018659
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 2, 2016
Generic Nameallopurinol

INGREDIENTS (7)

ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
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Allopurinol - FDA Approval | MedPath