01 2Aspen Pharmacare Holdings
02 6medac
03 8Accord healthcare
04 3Accure Labs
05 3Aurobindo Pharma Limited
06 2Bristol Laboratories Ltd
07 4Bristol Myers Squibb
08 3Fresenius Kabi USA
09 3GLAND PHARMA LIMITED
10 1Glaukos
11 3Health Biotech
12 6Hikma Pharmaceuticals
13 1Hospira, Inc.
14 3Inibsa Hospital, Slu
15 4Kyowa Kirin
16 1Leman Skl Sa
17 1Medac - Gesellschaft für klinische Spezialpräparate Gmbh - Wedel
18 3Meitheal Pharmaceuticals
19 4Naprod Life Sciences
20 2Nishchay Pharmaceuticals Pvt. Ltd.
21 3RK Pharma
22 3Regulix Gmbh
23 3Substipharm
24 1Sunovion Pharmaceuticals
25 1Teva Pharmaceutical Industries
26 2UroGen Pharma
27 1Viatris
01 1FOR SOLUTION;TOPICAL
02 2INJ
03 30INJECTABLE;INJECTION
04 5INJECTION
05 2Injection/Infusion Solution
06 4Lyophilised Injection
07 1Lyophillized Powder
08 1Mitomycin 10Mg 1 Unit Parenteral Use
09 1Mitomycin 40Mg 1 Unit Parenteral Use
10 3POWDER FOR SOLUTION
11 1POWDER;INTRAVESICAL
12 1POWDER;PYELOCALYCEAL
13 1Powder And Solvent For Intravesical Solution
14 2Powder For Injectable Solution
15 1Powder For Injection And Infusion Solution
16 7Powder For Intravesical Solution And Injectable Solution
17 1Powder and liquid to intravesikaloppløsning
18 10Solution For Injection
19 3Vial
01 4Allowed
02 3Approved
03 8Authorized
04 3Cancelled
05 11DISCN
06 5Deregistered
07 5Generic
08 2Originator
09 3Prescription
10 22RX
11 11Blank
01 1JELMYTO
02 24MITOMYCIN
03 1MITOMYCIN FOR INJECTION
04 1MITOMYCIN FOR INJECTION USP
05 1MITOMYCIN FOR INJECTION, USP
06 1MITOSOL
07 1MITOZYTREX
08 5MUTAMYCIN
09 1Metem
10 2Mitomycin
11 4Mitomycin Accord
12 2Mitomycin C
13 6Mitomycin Medac
14 1Mitomycin Mylan
15 2Mitomycin Substipharm
16 1Mitomycin medac
17 3Mitomycin-C
18 1Mitomycin-C 10 mg
19 1Mitomycin-C 2mg
20 1Mutamycin
21 1Nisocin 10
22 1Nisocin 2
23 3Urocin
24 1ZUSDURI
25 11Blank
01 3Canada
02 1France
03 12India
04 2Italy
05 1Norway
06 2South Africa
07 11Spain
08 8Sweden
09 4Switzerland
10 33USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mitomycin-C 2mg
Dosage Form : INJ
Dosage Strength : 2mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Mitomycin Medac
Dosage Form : Solution For Injection
Dosage Strength : 40mg
Packaging :
Approval Date : 08/01/2016
Application Number : 20131109000043
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mitomycin-C 10 mg
Dosage Form : INJ
Dosage Strength : 10mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Mitomycin Medac
Dosage Form : Solution For Injection
Dosage Strength : 20mg
Packaging :
Approval Date : 08/01/2016
Application Number : 20131109000050
Regulatory Info : Deregistered
Registration Country : Sweden
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mitomycin Medac
Dosage Form : Powder For Intravesical Solution And Injectable Solution
Dosage Strength : 20MG
Packaging :
Approval Date : 2017-01-13
Application Number : 81601
Regulatory Info : Authorized
Registration Country : Spain
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mitomycin Medac
Dosage Form : Powder For Intravesical Solution And Injectable Solution
Dosage Strength : 40MG
Packaging :
Approval Date : 2017-01-13
Application Number : 81602
Regulatory Info : Authorized
Registration Country : Spain
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mitomycin Medac
Dosage Form : Powder For Intravesical Solution And Injectable Solution
Dosage Strength : 2MG
Packaging :
Approval Date : 2017-01-13
Application Number : 81599
Regulatory Info : Authorized
Registration Country : Spain
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mitomycin Medac
Dosage Form : Powder For Intravesical Solution And Injectable Solution
Dosage Strength : 10MG
Packaging :
Approval Date : 2017-01-13
Application Number : 81600
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : RX
Registration Country : USA
Brand Name : MITOMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Packaging :
Approval Date : 1998-04-30
Application Number : 64144
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MUTAMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 50450
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MUTAMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1982-01-01
Application Number : 50450
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MUTAMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Packaging :
Approval Date : 1982-01-01
Application Number : 62336
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MUTAMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/VIAL
Packaging :
Approval Date : 1982-01-01
Application Number : 62336
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MUTAMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1988-03-10
Application Number : 62336
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MITOSOL
Dosage Form : FOR SOLUTION;TOPICAL
Dosage Strength : 0.2MG/VIAL
Packaging :
Approval Date : 2012-02-07
Application Number : 22572
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MITOMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL
Packaging :
Approval Date : 1995-04-19
Application Number : 64117
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MITOMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/VIAL
Packaging :
Approval Date : 1995-04-19
Application Number : 64117
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MITOMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 40MG/VIAL
Packaging :
Approval Date : 1999-06-02
Application Number : 64117
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MITOMYCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/VIAL
Packaging :
Approval Date : 1995-11-29
Application Number : 64106
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MITOZYTREX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2002-11-14
Application Number : 50763
Regulatory Info : DISCN
Registration Country : USA
