Details for New Drug Application (NDA): 062325
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NDA 062325 describes GENTAMICIN, which is a drug marketed by Intl Medication, 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-one NDAs. Additional details are available on the GENTAMICIN profile page.
The generic ingredient in GENTAMICIN 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 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 062325
| Tradename: | GENTAMICIN |
| Applicant: | Intl Medication |
| Ingredient: | gentamicin sulfate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Jun 23, 1982 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/100ML | ||||
| Approval Date: | Jun 23, 1982 | TE: | RLD: | No | |||||
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