Details for New Drug Application (NDA): 040811
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NDA 040811 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 040811
| Tradename: | INDOCYANINE GREEN |
| Applicant: | Renew Pharms |
| Ingredient: | indocyanine green |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 040811
Suppliers and Packaging for NDA: 040811
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 040811 | ANDA | Renew Pharmaceuticals Limited | 70100-424 | 70100-424-02 | 6 PACKAGE in 1 CARTON (70100-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) |
| INDOCYANINE GREEN | indocyanine green | INJECTABLE;INJECTION | 040811 | ANDA | Olympus America, Inc. | 73624-424 | 73624-424-02 | 6 PACKAGE in 1 CARTON (73624-424-02) / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/VIAL | ||||
| Approval Date: | Nov 21, 2007 | TE: | AP | RLD: | No | ||||
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