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 is included in one NDA. It is available from two suppliers. Additional details are available on the INDOCYANINE GREEN profile page.
The generic ingredient in INDOCYANINE GREEN is indocyanine green. There are three drug master file entries for this compound. Three 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 are three drug master file entries for this compound. Three 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 |
| Formulation / Manufacturing: | see details |
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: | RLD: | No | |||||
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