Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064117
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MITOMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
MITOMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
MITOMYCIN | MITOMYCIN | 40MG/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 |
---|---|---|---|---|---|---|---|
04/19/1995 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/17/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/02/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/02/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/02/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
06/02/1999 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
MITOMYCIN
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 |
INJECTABLE;INJECTION; 40MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MITOMYCIN | MITOMYCIN | 40MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064144 | ACCORD HLTHCARE |
MITOMYCIN | MITOMYCIN | 40MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216732 | EUGIA PHARMA |
MITOMYCIN | MITOMYCIN | 40MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211269 | FRESENIUS KABI USA |
MITOMYCIN | MITOMYCIN | 40MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216648 | GLAND PHARMA LTD |
MITOMYCIN | MITOMYCIN | 40MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064117 | HIKMA |
MITOMYCIN | MITOMYCIN | 40MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 214504 | MEITHEAL |
MITOMYCIN | MITOMYCIN | 40MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203386 | RK PHARMA |