Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075259
Company: MEITHEAL
Company: MEITHEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DACARBAZINE | DACARBAZINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
DACARBAZINE | DACARBAZINE | 200MG/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 |
---|---|---|---|---|---|---|---|
08/27/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75259ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/21/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/22/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
09/22/2000 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
DACARBAZINE
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DACARBAZINE | DACARBAZINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075812 | HIKMA |
DACARBAZINE | DACARBAZINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075259 | MEITHEAL |
INJECTABLE;INJECTION; 200MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DACARBAZINE | DACARBAZINE | 200MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075371 | FRESENIUS KABI USA |
DACARBAZINE | DACARBAZINE | 200MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075812 | HIKMA |
DACARBAZINE | DACARBAZINE | 200MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075940 | HOSPIRA |
DACARBAZINE | DACARBAZINE | 200MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 075259 | MEITHEAL |