Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040811
Company: RENEW PHARMS
Company: RENEW PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDOCYANINE GREEN | INDOCYANINE GREEN | 25MG/VIAL | INJECTABLE;INJECTION | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
11/21/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040811s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
02/11/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |