NDC 68083-483

MITOMYCIN

Mitomycin

MITOMYCIN is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Mitomycin.

Product ID68083-483_64496224-9cec-48bb-a750-db192dd7780c
NDC68083-483
Product TypeHuman Prescription Drug
Proprietary NameMITOMYCIN
Generic NameMitomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-10-20
Marketing CategoryANDA /
Application NumberANDA215687
Labeler NameGland Pharma Limited
Substance NameMITOMYCIN
Active Ingredient Strength5 mg/10mL
Pharm ClassesAlkylating Activity [MoA],Alkylating Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68083-483-01

1 VIAL in 1 CARTON (68083-483-01) > 10 mL in 1 VIAL
Marketing Start Date2021-10-20
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
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