Details for New Drug Application (NDA): 062365
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NDA 062365 describes CHLORAMPHENICOL SODIUM SUCCINATE, which is a drug marketed by Fresenius Kabi Usa and Gruppo Lepetit and is included in two NDAs. It is available from one supplier. Additional details are available on the CHLORAMPHENICOL SODIUM SUCCINATE profile page.
The generic ingredient in CHLORAMPHENICOL SODIUM SUCCINATE is chloramphenicol sodium succinate. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chloramphenicol sodium succinate profile page.
The generic ingredient in CHLORAMPHENICOL SODIUM SUCCINATE is chloramphenicol sodium succinate. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chloramphenicol sodium succinate profile page.
Summary for 062365
| Tradename: | CHLORAMPHENICOL SODIUM SUCCINATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | chloramphenicol sodium succinate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062365
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHLORAMPHENICOL SODIUM SUCCINATE | chloramphenicol sodium succinate | INJECTABLE;INJECTION | 062365 | ANDA | Fresenius Kabi USA, LLC | 63323-011 | 63323-011-15 | 10 VIAL in 1 TRAY (63323-011-15) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Aug 25, 1982 | TE: | RLD: | No | |||||
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