Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090874
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSULFAN BLUE | ISOSULFAN BLUE | 1% | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/20/2010 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090874s000ltr.pdf |
ISOSULFAN BLUE
INJECTABLE;INJECTION; 1%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISOSULFAN BLUE | ISOSULFAN BLUE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 206831 | AUROBINDO PHARMA LTD |
| ISOSULFAN BLUE | ISOSULFAN BLUE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 090874 | MYLAN INSTITUTIONAL |
| ISOSULFAN BLUE | ISOSULFAN BLUE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 210558 | SOMERSET THERAPS LLC |
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