NDC 67457-996

Mitomycin

Mitomycin

Mitomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Mitomycin.

Product ID67457-996_96d60181-8337-4bac-99ff-811b836b0112
NDC67457-996
Product TypeHuman Prescription Drug
Proprietary NameMitomycin
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-10-13
Marketing CategoryANDA / ANDA
Application NumberANDA202670
Labeler NameMylan Institutional LLC
Substance NameMITOMYCIN
Active Ingredient Strength20 mg/40mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67457-996-20

1 VIAL in 1 CARTON (67457-996-20) > 40 mL in 1 VIAL
Marketing Start Date2020-08-28
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Mitomycin" or generic name "Mitomycin"

NDCBrand NameGeneric Name
0143-9135MitomycinMitomycin
0143-9136MitomycinMitomycin
0143-9279MitomycinMitomycin
0143-9280MitomycinMitomycin
16729-108MitomycinMitomycin
16729-115MitomycinMitomycin
16729-116MitomycinMitomycin
16729-246MitomycinMitomycin
16729-247MitomycinMitomycin
16729-248MitomycinMitomycin
67457-518MitomycinMitomycin
67457-519MitomycinMitomycin
67457-520MitomycinMitomycin
67457-995MitomycinMitomycin
67457-996MitomycinMitomycin
67457-997MitomycinMitomycin
68001-389MitomycinMitomycin
68001-390MitomycinMitomycin
68001-391MitomycinMitomycin
68083-483MITOMYCINMITOMYCIN
68083-484MITOMYCINMITOMYCIN
68083-502MITOMYCINMITOMYCIN
71288-137MITOMYCINMITOMYCIN
71288-138MITOMYCINMITOMYCIN
69605-103JELMYTOmitomycin
49771-002Mitosolmitomycin
69448-001MUTAMYCINMitomycin
69448-002MUTAMYCINMitomycin
69448-003MUTAMYCINMitomycin
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.