Details for New Drug Application (NDA): 062413
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NDA 062413 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Padagis Us, Pharmaderm, Sun Pharma Canada, Abbott, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, Wyeth Ayerst, Fera Pharms Llc, Sciegen Pharms, 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 nineteen 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-two 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-two suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062413
| Tradename: | GENTAMICIN SULFATE |
| Applicant: | Abbott |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.2MG BASE/ML | ||||
| Approval Date: | Aug 11, 1983 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.4MG BASE/ML | ||||
| Approval Date: | Aug 11, 1983 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.6MG BASE/ML | ||||
| Approval Date: | Aug 11, 1983 | TE: | RLD: | No | |||||
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