Details for New Drug Application (NDA): 218579
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NDA 218579 describes ZYOGREEN, which is a drug marketed by Provepharm Sas and is included in one NDA. It is available from one supplier. Additional details are available on the ZYOGREEN profile page.
The generic ingredient in ZYOGREEN is indocyanine green. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
The generic ingredient in ZYOGREEN is indocyanine green. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the indocyanine green profile page.
Summary for 218579
| Tradename: | ZYOGREEN |
| Applicant: | Provepharm Sas |
| Ingredient: | indocyanine green |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 218579
Suppliers and Packaging for NDA: 218579
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYOGREEN | indocyanine green | SOLUTION;INTRAVENOUS, INTERSTITIAL | 218579 | NDA | Sagent Pharmaceuticals | 25021-841 | 25021-841-10 | 5 AMPULE in 1 CARTON (25021-841-10) / 10 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS, INTERSTITIAL | Strength | 25MG/10ML (2.5MG/ML) | ||||
| Approval Date: | Jul 10, 2026 | TE: | RLD: | Yes | |||||
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