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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011525
Company: RENEW PHARMS

Products on NDA 011525

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IC-GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	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IC-GREEN	INDOCYANINE GREEN	50MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No
IC-GREEN	INDOCYANINE GREEN	10MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No
IC-GREEN	INDOCYANINE GREEN	40MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011525

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
12/05/2024	SUPPL-39	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/011525Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/011525Orig1s039ltr.pdf
03/17/2022	SUPPL-36	Labeling-Package Insert, Labeling-Container/Carton Labels	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.

Labels for NDA 011525

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2024	SUPPL-39	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/011525Orig1s039lbl.pdf
03/17/2022	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/011525Orig1s036lbl.pdf
03/17/2022	SUPPL-36	Labeling-Container/Carton Labels	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

Therapeutic Equivalents for NDA 011525

IC-GREEN

INJECTABLE;INJECTION; 25MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IC-GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	011525	RENEW PHARMS
INDOCYANINE GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040811	RENEW PHARMS

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