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Serving 500+ biopharmaceutical companies globally:

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Generated: September 22, 2017

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Details for New Drug Application (NDA): 065024

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NDA 065024 describes GENTAMICIN SULFATE, which is a drug marketed by Teva Parenteral, Perrigo New York, Solopak, Hospira, Abbott, Watson Labs, Perrigo Co Tennessee, Alcon Pharms Ltd, Taro, Pharmaderm, Fougera Pharms Inc, Paco, Akorn, Pharm Spec, Bausch And Lomb, West-ward Pharms Int, Kalapharm, G And W Labs Inc, Fresenius Kabi Usa, Wyeth Ayerst, Alpharma Us Pharms, Sandoz Inc, B Braun, and Baxter Hlthcare, and is included in thirty-seven NDAs. It is available from twenty-one 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. Thirty suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.

Summary for NDA: 065024

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065024


Suppliers and Packaging for NDA: 065024

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
gentamicin sulfate
OINTMENT;OPHTHALMIC 065024 ANDA Paddock Laboratories, LLC 0574-4102 0574-4102-35 1 TUBE in 1 CARTON (0574-4102-35) > 3.5 g in 1 TUBE
gentamicin sulfate
OINTMENT;OPHTHALMIC 065024 ANDA Physicians Total Care, Inc. 54868-1040 54868-1040-1 3.5 g in 1 TUBE (54868-1040-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:Jul 30, 2004TE:ATRLD:No

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Boehringer Ingelheim

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