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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 062635


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NDA 062635 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, Akorn, Fera Pharms Llc, 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-two 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-six suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062635
Tradename:GENTAMICIN SULFATE
Applicant:Epic Pharma Llc
Ingredient:gentamicin sulfate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Jan 8, 1987TE:RLD:No

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