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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219139
Company: ZYDUS LIFESCIENCES

Products on ANDA 219139

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOCYANINE GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219139

INDOCYANINE 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
INDOCYANINE GREEN	INDOCYANINE GREEN	25MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	219139	ZYDUS LIFESCIENCES

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