NDC 0078-0716

TABRECTA

Capmatinib

TABRECTA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Capmatinib.

Product ID0078-0716_09072608-375f-4c64-b09a-8fc453868473
NDC0078-0716
Product TypeHuman Prescription Drug
Proprietary NameTABRECTA
Generic NameCapmatinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-05-06
Marketing CategoryNDA / NDA
Application NumberNDA213591
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameCAPMATINIB
Active Ingredient Strength200 mg/1
Pharm ClassesBreast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], Mesenchymal Epithelial Transition Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0716-56

56 TABLET, FILM COATED in 1 BOTTLE (0078-0716-56)
Marketing Start Date2020-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0716-94 [00078071694]

TABRECTA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA213591
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-06

NDC 0078-0716-56 [00078071656]

TABRECTA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA213591
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-06

Drug Details

Active Ingredients

IngredientStrength
CAPMATINIB200 mg/1

NDC Crossover Matching brand name "TABRECTA" or generic name "Capmatinib"

NDCBrand NameGeneric Name
0078-0709TABRECTAcapmatinib
0078-0716TABRECTAcapmatinib

Trademark Results [TABRECTA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TABRECTA
TABRECTA
79281021 not registered Live/Pending
NOVARTIS AG
2020-01-22
TABRECTA
TABRECTA
79148570 4630489 Live/Registered
NOVARTIS AG
2014-03-21

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