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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011525

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IC-GREEN (INDOCYANINE GREEN)
10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: INDOCYANINE GREEN
Proprietary Name: IC-GREEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011525
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RENEW PHARMACEUTICALS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
IC-GREEN (INDOCYANINE GREEN)
25MG/VIAL
Marketing Status: Discontinued
Active Ingredient: INDOCYANINE GREEN
Proprietary Name: IC-GREEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 25MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011525
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RENEW PHARMACEUTICALS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
IC-GREEN (INDOCYANINE GREEN)
40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: INDOCYANINE GREEN
Proprietary Name: IC-GREEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011525
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RENEW PHARMACEUTICALS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
IC-GREEN (INDOCYANINE GREEN)
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: INDOCYANINE GREEN
Proprietary Name: IC-GREEN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N011525
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: RENEW PHARMACEUTICALS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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