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Generated: June 28, 2017

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Details for New Drug Application (NDA): 064048

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NDA 064048 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: 064048

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 064048

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 064048

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENTAMICIN SULFATE
gentamicin sulfate
 SOLUTION/DROPS;OPHTHALMIC 064048 ANDA Bausch & Lomb Incorporated 24208-580 24208-580-60 1 BOTTLE, DROPPER in 1 CARTON (24208-580-60) > 5 mL in 1 BOTTLE, DROPPER
GENTAMICIN SULFATE
gentamicin sulfate
 SOLUTION/DROPS;OPHTHALMIC 064048 ANDA Bausch & Lomb Incorporated 24208-580 24208-580-64 1 BOTTLE, DROPPER in 1 CARTON (24208-580-64) > 15 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.3% BASE
Approval Date:May 11, 1994TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Chubb
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QuintilesIMS
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Moodys
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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