NDC 0378-1201

Sorafenib Tosylate

Sorafenib

Sorafenib Tosylate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Sorafenib Tosylate.

Product ID0378-1201_347ec24f-101b-403d-a5bb-539a8afdfca5
NDC0378-1201
Product TypeHuman Prescription Drug
Proprietary NameSorafenib Tosylate
Generic NameSorafenib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-03-21
Marketing CategoryANDA /
Application NumberANDA207012
Labeler NameMylan Pharmaceuticals Inc.
Substance NameSORAFENIB TOSYLATE
Active Ingredient Strength200 mg/1
Pharm ClassesKinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-1201-78

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1201-78)
Marketing Start Date2022-06-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Sorafenib Tosylate" or generic name "Sorafenib"

NDCBrand NameGeneric Name
0378-1201Sorafenib TosylateSorafenib
50419-488Nexavarsorafenib
0480-5425SorafenibSorafenib
24979-715SorafenibSorafenib
43598-458sorafenibsorafenib
51990-201SorafenibSorafenib

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