Details for New Drug Application (NDA): 062366
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NDA 062366 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Taro, Abbott, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, Wyeth Ayerst, Fera Pharms Llc, Sciegen Pharms Inc, Encube, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Paco, Sandoz, B Braun, and Baxter Hlthcare, and is included in forty NDAs. It is available from twenty-three suppliers. Additional details are available on the GENTAMICIN SULFATE profile page.
The generic ingredient in GENTAMICIN SULFATE 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 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 062366
| Tradename: | GENTAMICIN SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062366
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | gentamicin sulfate | INJECTABLE;INJECTION | 062366 | ANDA | Henry Schein, Inc | 0404-9866 | 0404-9866-20 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9866-20) / 20 mL in 1 VIAL, MULTI-DOSE |
| GENTAMICIN SULFATE | gentamicin sulfate | INJECTABLE;INJECTION | 062366 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1508 | 51662-1508-3 | 25 POUCH in 1 BOX (51662-1508-3) / 1 VIAL in 1 POUCH (51662-1508-2) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
| Approval Date: | Aug 4, 1983 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Feb 6, 1986 | TE: | AP | RLD: | No | ||||
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