Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AstraZeneca PLC
230790719
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lynparza
Product Details
NDC Product Code
0310-0668Application Number
NDA208558Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 6, 2023FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
OlaparibActive
Code: WOH1JD9AR8Class: ACTIBQuantity: 100 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Lynparza
Product Details
NDC Product Code
0310-0679Application Number
NDA208558Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 6, 2023OlaparibActive
Code: WOH1JD9AR8Class: ACTIBQuantity: 150 mg in 1 1
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT