Details for New Drug Application (NDA): 219139
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NDA 219139 describes INDOCYANINE GREEN, which is a drug marketed by Renew Pharms and Zydus Lifesciences and is included in two NDAs. It is available from four suppliers. Additional details are available on the INDOCYANINE GREEN profile page.
The generic ingredient in INDOCYANINE GREEN 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 INDOCYANINE GREEN 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 219139
| Tradename: | INDOCYANINE GREEN |
| Applicant: | Zydus Lifesciences |
| Ingredient: | indocyanine green |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 219139
Suppliers and Packaging for NDA: 219139
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 219139 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-2018 | 70710-2018-3 | 6 KIT in 1 CARTON (70710-2018-3) / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70710-2031-1) * 6 VIAL in 1 CARTON (70710-2032-8) / 10 mL in 1 VIAL (70710-2032-1) |
| INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 219139 | ANDA | Zydus Lifesciences Limited | 70771-1961 | 70771-1961-3 | 6 PACKAGE in 1 CARTON (70771-1961-3) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70771-1959-1) * 6 VIAL in 1 CARTON (70771-1960-8) / 10 mL in 1 VIAL (70771-1960-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/VIAL | ||||
| Approval Date: | Aug 3, 2026 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jan 31, 2027 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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