Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011525
Company: RENEW PHARMS
Company: RENEW PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IC-GREEN | INDOCYANINE GREEN | 25MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
IC-GREEN | INDOCYANINE GREEN | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
IC-GREEN | INDOCYANINE GREEN | 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
IC-GREEN | INDOCYANINE GREEN | 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
02/09/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/17/2022 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011525Orig1s036lbl.pdf | |
08/08/2022 | SUPPL-31 | Manufacturing (CMC)-Manufacturing Process |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/005939Orig1s012;011525Orig1s031;012015Orig1s036;016619Orig1s045;019353Orig1s024;208609Orig1s006correctedltr.pdf |
10/05/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011525s027lbl.pdf | |
09/22/2006 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011525s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011525s017LTR.pdf | |
03/02/1998 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/21/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/30/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/30/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/05/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
08/02/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/17/2022 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011525Orig1s036lbl.pdf | |
03/17/2022 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011525Orig1s036lbl.pdf | |
10/05/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011525s027lbl.pdf | |
09/22/2006 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011525s017lbl.pdf |