Manufacturing Establishments (4)
Pfizer Pharmaceuticals LLC
U.S. Pharmaceuticals
829084552
Pfizer Ireland Pharmaceuticals
U.S. Pharmaceuticals
985052076
Pharmacia & Upjohn Company LLC
U.S. Pharmaceuticals
618054084
Pfizer Manufacturing Deutschland GmbH
U.S. Pharmaceuticals
341970073
Products (1)
Lorbrena
63539-927
NDA210868
NDA (C73594)
ORAL
March 22, 2023
lorlatinibActive
Code: OSP71S83EUClass: ACTIBQuantity: 25 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT