Basic Information
Lorbrena
0069-0227
Regulatory Information
0069-0227
NDA210868
C73594
April 10, 2023
USA
These highlights do not include all the information needed to use LORBRENA safely and effectively. See full prescribing information for LORBRENA. LORBRENA (lorlatinib) tablets, for oral use Initial U.S. Approval: 2018
HUMAN PRESCRIPTION DRUG LABEL
7
Company Information
Pfizer Laboratories Div Pfizer Inc
134489525
Active Ingredients
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Code: L11K75P92J
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
TRIACETIN
Code: XHX3C3X673
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
Active Moieties
LORLATINIB
Code: OSP71S83EU