Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064180
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/23/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64180ltr.pdf |
MITOMYCIN
INJECTABLE;INJECTION; 5MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064144 | ACCORD HLTHCARE |
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216732 | EUGIA PHARMA |
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211269 | FRESENIUS KABI USA |
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215687 | GLAND PHARMA LTD |
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064180 | HIKMA |
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214505 | MEITHEAL |
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202670 | RK PHARMA |
INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064144 | ACCORD HLTHCARE |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216732 | EUGIA PHARMA |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211269 | FRESENIUS KABI USA |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215687 | GLAND PHARMA LTD |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064117 | HIKMA |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064180 | HIKMA |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214505 | MEITHEAL |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202670 | RK PHARMA |