Pazopanib
Initial U.S. Approval:
Approved
Approval ID
9f7ea520-a152-401e-b1f7-b5ef8c7a2239
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2023
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pazopanib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-4184
Application NumberANDA217517
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pazopanib
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2023
FDA Product Classification
INGREDIENTS (11)
PAZOPANIB HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 33Y9ANM545
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT