Lynparza
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . LYNPARZA (olaparib) tablets, for oral useInitial U.S. Approval: 2014
Approved
Approval ID
741ff3e3-dc1a-45a6-84e5-2481b27131aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2023
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
olaparib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-0668
Application NumberNDA208558
Product Classification
M
Marketing Category
C73594
G
Generic Name
olaparib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (11)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OLAPARIBActive
Quantity: 100 mg in 1 1
Code: WOH1JD9AR8
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
olaparib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-0679
Application NumberNDA208558
Product Classification
M
Marketing Category
C73594
G
Generic Name
olaparib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2023
FDA Product Classification
INGREDIENTS (11)
OLAPARIBActive
Quantity: 150 mg in 1 1
Code: WOH1JD9AR8
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT