Details for New Drug Application (NDA): 062373
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NDA 062373 describes GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, and Hospira, and is included in four NDAs. It is available from one supplier. Additional details are available on the GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
The generic ingredient in GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062373
| Tradename: | GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062373
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | gentamicin sulfate | INJECTABLE;INJECTION | 062373 | ANDA | Baxter Healthcare Corporation | 0338-0503 | 0338-0503-48 | 100 mL in 1 BAG (0338-0503-48) |
| GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | gentamicin sulfate | INJECTABLE;INJECTION | 062373 | ANDA | Baxter Healthcare Corporation | 0338-0505 | 0338-0505-48 | 100 mL in 1 BAG (0338-0505-48) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.8MG BASE/ML | ||||
| Approval Date: | Sep 7, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 80MG BASE/100ML | ||||
| Approval Date: | Sep 7, 1982 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/100ML | ||||
| Approval Date: | Sep 7, 1982 | TE: | RLD: | No | |||||
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